Film, Camera, Surgical
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
What Is FDA Product Code FXT?
Film, Camera, Surgical is FDA product code FXT, 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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