Dynacare Necessities Complete Kit
Kits Contents: 2 Regular Tampons Plastic Applicator 1 Maxi Pad Super w/Wings 1 Maxi Pad Ultra Thin w/Wings 2 Feminine Hygiene Wipes
Maternity Kit
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Fujian and Shandong.
- Fujian Time AND Tianhe Industrial Co., Ltd. Fujian, contract manufacturer
- Hynaut Health Technology Co., Ltd. Shandong, contract manufacturer
What Is It?
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
What Is FDA Product Code PVT?
Maternity Kit is FDA product code PVT, Class 1, 21 CFR 884.5435.
How Does It Reach the US Market?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
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Dynacare HerCare Necessities Complete Kit
Kit Contents: 2 Maxi Pads Super w/Wings 2 Maxi Pads Ultra Thin w/Wings 2 Feminine Hygiene Wipes