Lapping Tool Kit
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Shanghai and Hunan: 3 hold an FDA registration.
- Changsha Nice Medical Instrument Limited Company Hunan
- Shanghai Lions Industrial Co., Ltd. Shanghai, contract manufacturer
- Shanghai Jolly Industrial Co., Ltd. Shanghai, contract manufacturer
What Is This Device?
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. 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 NYG?
Lapping Tool Kit is FDA product code NYG, Class 1, 21 CFR 872.4565.
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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