Tracoe® Comfort
Extra-Long Tube, double fenestrated, with 2 Inner tubes, one with with 15 mm Connector (double fenestrated + swivel speaking valve type B), one with 22 mm Adapter (double fenestrated)
1manufacturer
1,296catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Tracoe Medical Gmbh, Germany |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K781729 |
| Record published | 2017-07-03 |
| Record revised | 2025-05-08 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Products must be stored in cool and dry location. Temporary storage for less or equal to 30 days at less or equal to +50 |
| Sizes | Lumen/inner diameter 2.6 to 14 mm |
| Distribution end date | 2025-03-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REF 214-06 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 202-05D | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 888-102-10 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 888-102-09D | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 888-105-11-1D | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 205-11-2 | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 114-09 | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 114-08 | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 104-05 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 215-12-2 | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 888-205-12-1 | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 104-12N | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 205-05-2 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 205-12-2 | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 101-09 | Lumen/Inner Diameter 9.0 mm | In distribution |
| REF 888-101-11 | Lumen/Inner Diameter 11.0 mm | In distribution |
| REF 888-103-06 | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 204-10A | Lumen/Inner Diameter 8.8 mm | In distribution |
| REF 205-11-1 | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 104-05A-N | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 888-104-10A | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 888-103-05A-N | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 108-06 | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 888-105-12-2 | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 108-07 | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 104-10N | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 203-09A | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 888-115-07-2 | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 105-09-2 | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 888-202-10 | Lumen/Inner Diameter 8.8 mm | In distribution |
| REF 888-101-08 | Lumen/Inner Diameter 8.0 mm | In distribution |
| REF 105-11-1 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 103-05 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 105-11-1D | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 103-12-O | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 888-204-06A | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 115-13-2 | Lumen/Inner Diameter 11.8 mm | In distribution |
| REF 203-07N | Lumen/Inner Diameter 7.0 mm | In distribution |
| REF 888-103-08A | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 888-104-08A | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 888-101-07 | Lumen/Inner Diameter 7.0 mm | In distribution |
| REF 115-10-2 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 888-204-07A | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 203-07A | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 205-05-1 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 103-10A-O | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 214-11 | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 103-10-O | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 888-114-09 | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 888-115-11-2 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 204-11A-N | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 204-07A-O | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 101-10 | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 203-08-O | Lumen/Inner Diameter 6.7 mm | In distribution |
| REF 888-114-12 | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 203-11 | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 202-09 | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 157-10 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 104-08 | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 105-12-1 | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 104-08A | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 204-12N | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 108-11 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 888-205-10-2 | Lumen/Inner Diameter 8.8 mm | In distribution |
| REF 105-05-1 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 104-12A-O | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 888-102-08 | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 203-05-O | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 214-12 | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 104-12A | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 204-06N | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 204-10 | Lumen/Inner Diameter 8.8 mm | In distribution |
| REF 888-115-09-2 | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 164-10 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 888-103-10A | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 888-104-09N | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 107-12 | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 888-204-11A | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 888-205-09-1 | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 204-11 | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 104-06A-N | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 888-205-11-2 | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 204-11A | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 215-09-2 | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 204-12 | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 888-103-10 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 888-103-12A | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 203-07 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 204-11A-O | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 888-215-06-2 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 202-12 | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 888-202-05D | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 205-10-2 | Lumen/Inner Diameter 8.8 mm | In distribution |
| REF 104-11A | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 205-12-1 | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 202-12D | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 204-07A-N | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 888-103-06A | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 204-10N | Lumen/Inner Diameter 8.8 mm | In distribution |
| REF 202-09D | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 104-11A-N | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 888-204-09A | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 158-10 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 108-10 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 204-05 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 105-08-1D | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 888-105-11-1 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 204-10A-N | Lumen/Inner Diameter 8.8 mm | In distribution |
| REF 102-06D | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 103-07A-O | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 115-09-2 | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 888-105-08-1D | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 888-115-12-2 | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 105-10-1D | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 104-05A-O | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 203-10N | Lumen/Inner Diameter 8.8 mm | In distribution |
| REF 215-13-2 | Lumen/Inner Diameter 11.8 mm | In distribution |
| REF 888-202-09D | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 888-101-12 | Lumen/Inner Diameter 12.0 mm | In distribution |
| REF 888-105-10-1 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 204-06 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 157-09 | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 102-08D | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 102-11 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 204-05A-N | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 204-12A-O | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 888-102-12D | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 203-06N | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 104-10A-O | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 214-09 | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 888-105-08-2D | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 888-105-09-1D | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 888-202-05 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 888-105-05-1D | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 203-11A | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 888-101-09 | Lumen/Inner Diameter 9.0 mm | In distribution |
| REF 888-105-06-2D | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 105-11-2 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 104-05N | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 158-11 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 888-101-10 | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 105-12-2 | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 103-09N | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 157-11 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 202-05 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 103-09A | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 202-06D | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 103-09A-O | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 164-11 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 888-215-12-2 | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 204-08N | Lumen/Inner Diameter 6.7 mm | In distribution |
| REF 888-105-07-2 | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 888-103-12 | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 105-06-1D | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 888-204-05A | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 888-103-07A-N | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 888-105-10-2 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 104-06 | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 115-11-2 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 888-104-05A-N | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 888-215-11-2 | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 888-114-10 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 888-103-08 | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 204-09A | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 888-215-08-2 | Lumen/Inner Diameter 6.7 mm | In distribution |
| REF 203-05A | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 102-11D | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 102-07 | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 158-08 | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 888-205-07-1 | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 101-08 | Lumen/Inner Diameter 8.0 mm | In distribution |
| REF 103-05N | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 203-09N | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 202-08D | Lumen/Inner Diameter 6.7 mm | In distribution |
| REF 215-05-2 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 204-06A-N | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 114-07 | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 105-07-1D | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 888-104-10A-N | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 104-08N | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 888-105-07-2D | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 205-09-2 | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 888-215-14-2 | Lumen/Inner Diameter 12.6 mm | In distribution |
| REF 103-07A | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 103-06A | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 114-11 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 204-05A | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 888-104-05 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 203-09-O | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 103-09-O | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 202-11 | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 888-104-07 | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 104-12 | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 888-202-07D | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 888-102-10D | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 104-09 | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 114-06 | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 215-07-2 | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 888-205-08-1 | Lumen/Inner Diameter 6.7 mm | In distribution |
| REF 107-11 | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 105-10-2 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 104-08A-O | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 203-11-O | Lumen/Inner Diameter 9.2 mm | In distribution |
| REF 888-104-07N | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 114-10 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 204-06A | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 103-05A-O | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 204-09N | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 888-103-11A | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 101-05 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 204-06A-O | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 115-07-2 | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 205-09-1 | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 888-104-11N | Lumen/Inner Diameter 9.7 mm | In distribution |
| REF 103-08-O | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 104-06N | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 888-105-09-2 | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 888-102-08D | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 203-12N | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 204-09A-O | Lumen/Inner Diameter 7.5 mm | In distribution |
| REF 203-10A | Lumen/Inner Diameter 8.8 mm | In distribution |
| REF 204-05N | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 888-104-05A | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 157-08 | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 888-202-08D | Lumen/Inner Diameter 6.7 mm | In distribution |
| REF 888-104-08N | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 888-104-06A-N | Lumen/Inner Diameter 4.8 mm | In distribution |
| REF 888-102-07D | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 888-114-05 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 888-215-05-2 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 203-08A | Lumen/Inner Diameter 6.7 mm | In distribution |
| REF 104-10 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 888-115-10-2 | Lumen/Inner Diameter 8.7 mm | In distribution |
| REF 888-115-08-2 | Lumen/Inner Diameter 6.8 mm | In distribution |
| REF 204-08A | Lumen/Inner Diameter 6.7 mm | In distribution |
| REF 888-205-05-1 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 203-12A | Lumen/Inner Diameter 10.0 mm | In distribution |
| REF 108-05 | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 203-05N | Lumen/Inner Diameter 4.0 mm | In distribution |
| REF 214-08 | Lumen/Inner Diameter 6.7 mm | In distribution |
| REF 888-104-09A | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 205-08-1 | Lumen/Inner Diameter 6.7 mm | In distribution |
| REF 104-09N | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 888-202-06 | Lumen/Inner Diameter 5.0 mm | In distribution |
| REF 101-11 | Lumen/Inner Diameter 11.0 mm | In distribution |
| REF 202-07D | Lumen/Inner Diameter 6.0 mm | In distribution |
| REF 105-09-1 | Lumen/Inner Diameter 7.6 mm | In distribution |
| REF 108-12 | Lumen/Inner Diameter 10.8 mm | In distribution |
| REF 105-07-2 | Lumen/Inner Diameter 5.8 mm | In distribution |
| REF 888-103-07 | Lumen/Inner Diameter 5.8 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 380 |
| Pilling | Teleflex Medical LLC | 248 |
| Premier | Premier Dental Products Co. | 111 |
| Tracoe mini | Tracoe Medical Gmbh | 110 |
| Sklar® | Sklar Corporation | 70 |
| Laryngotec | Andreas Fahl Medizintechnik-Vertrieb GmbH | 66 |
| Blom | Pulmodyne Inc. | 51 |
| Montgomery® Long-Term Cannula | Boston Medical Products, Inc. | 48 |
| Bivona | ICU Medical, Inc | 37 |
| Well Lead Tracheostomy Tube | Well Lead Medical Co., Ltd. | 36 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 36 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 30 |
Showing 12 of 77. All products under Tube, Tracheostomy (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K051587 | 2005-10-25 |
| K781729 | 1978-10-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.