Crusher, Spur, Colostomy
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Zhejiang.
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
What Is FDA Product Code FHH?
Crusher, Spur, Colostomy is FDA product code FHH, Class 1, 21 CFR 876.4730.
What Does It Take to Sell It in the United States?
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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