Ring, Crimp
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Shandong.
- Xinhua Surgical Instrument Co., Ltd. Shandong
How Is FJX Classified?
Ring, Crimp is FDA product code FJX, Class 1, 21 CFR 876.5540.
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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