Surgical Direct
3mm Biopsy Cup Forcep, Straight
Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical
Who Makes This Device Type in China?
2 of the 5 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Guangdong, Jiangsu and Hebei.
- Changzhou Major Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Changzhou Meiguan Care Products Technology Co., Ltd. Jiangsu
- Dongguan NAN YOU Sporting Goods Enterprise Ltd Guangdong, contract manufacturer
- Hengshui Gangsheng Medical Instruments Co., Ltd. Hebei, contract manufacturer
- Zhongshan Chukuang Textile Co., Ltd. Guangdong, contract manufacturer
What Is FDA Product Code KFT?
Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical is FDA product code KFT, Class 1, 21 CFR 890.3420.
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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