Head, Surgical, Hammer
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Shandong and Shanghai: 2 hold an FDA registration.
- Shanghai Lange Medtech Co., Ltd. Shanghai
- Xinhua Surgical Instrument Co., Ltd. Shandong
How Is GFB Classified?
Head, Surgical, Hammer is FDA product code GFB, Class 1, 21 CFR 878.4820.
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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