Lens, Camera, Surgical
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
- Suzhou SMH Co., Ltd. Jiangsu
How Is FXQ Classified?
Lens, Camera, Surgical is FDA product code FXQ, Class 1, 21 CFR 878.4160.
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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