Fibrin Sealant Preparation Device
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Shanghai.
- Shanghai JPY ION-Tech Co., Ltd. Shanghai, contract manufacturer
- Tessy Plastics Shanghai Co., Ltd. Shanghai, contract manufacturer
What Is FDA Product Code MZM?
Fibrin Sealant Preparation Device is FDA product code MZM, Class 2, 21 CFR 880.5860.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
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