Prism, Rotary, Ophthalmic
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Beijing and Jiangsu: 2 hold an FDA registration. 1 is a contract manufacturer.
- Beijing Hongdee Corporation Beijing
- Wuxi Zontai Int'l Corporation Ltd. Jiangsu, contract manufacturer
How Is HKQ Classified?
Prism, Rotary, Ophthalmic is FDA product code HKQ, Class 1, 21 CFR 886.1665.
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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