Selector, Color, Spectacle, Lens, Tint
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Fujian and Zhejiang: 2 hold an FDA registration.
- HWA MAO Optical (Xiamen) Co., Ltd. Fujian
- Wenzhou Sutar Trading Co., Ltd. Zhejiang
What Is FDA Product Code NFD?
Selector, Color, Spectacle, Lens, Tint is FDA product code NFD, Class 1, 21 CFR 886.1160.
How Does It Reach the US Market?
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.
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