Punch, Gelfoam, Non-Sterile
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Jiangsu: 2 hold an FDA registration.
- Haimen Shengbang Laboratory Equipment Co., Ltd. Jiangsu
- Suzhou Texnet Jiangsu, contract manufacturer
What Is It?
Prosthesis modification instrument for ossicular replacement surgery; see product code JXZ
How Is NNT Classified?
Punch, Gelfoam, Non-Sterile is FDA product code NNT, Class 1, 21 CFR 874.3540.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.
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