AMO (Hangzhou Park) Warehouse
Registered establishment in Hangzhou, Zhejiang, China. 1 device type.
AMO (Hangzhou Park) Warehouse is an exporter holding a current FDA establishment registration. The registration covers Accessories, Soft Lens Products. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | AMO (HANGZHOU PARK) WAREHOUSE |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011714173 |
| FEI number | 3011714173 |
| Establishment type | Exporter |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | WenJin North Road No. 501 |
| Postal code | 310018 |
| Country | China |
Group
AMO (Hangzhou Park) Warehouse is one of 2 plants registered under Johnson & Johnson Surgical Vision, Inc..
| Plant | City | Device types |
|---|---|---|
| AMO (Hangzhou) Co., Ltd. | Hangzhou | 2 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Soft Lens Products | Class 2 | Accessories, soft lens products, Case, Contact Lens | 2016 | 2 |
Clearances
No clearance names AMO (Hangzhou Park) Warehouse as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K093254 | 2010-09-15 | LPN | Traditional | Abbott Medical Optics, Inc. |
| K014202 | 2002-02-20 | LPN | Traditional | Allergan |
| K984383 | 1998-12-18 | LPN | Special | Allergan |
PMA Approvals
A premarket approval is the Class III route: granted on clinical evidence, not on equivalence to a device already on the market.
| PMA number | Decision | Trade name | Product code | Held by |
|---|---|---|---|---|
| P850088 | 1991-03-21 | LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET | LPN | Advanced Medical Optics, Inc. |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.