Solution, Formol Calcium
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Jilin: 3 hold an FDA registration. 1 is a contract manufacturer.
- Changchun Merydi BIO-Tech Co., Ltd. Jilin
- Changchun Wancheng BIO-Electron Co., Ltd. Jilin, contract manufacturer
- Jilin Hongyi BIO-Tech Co., Ltd. Jilin
How Is IGD Classified?
Solution, Formol Calcium is FDA product code IGD, Class 1, 21 CFR 864.4010.
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. It is also exempt from most of the quality system regulation.
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