Spectacle Microscope, Low-Vision
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
- Wuxi Zontai Int'l Corporation Ltd. Jiangsu, contract manufacturer
How Is HKC Classified?
Spectacle Microscope, Low-Vision is FDA product code HKC, Class 1, 21 CFR 886.5540.
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. It is also exempt from most of the quality system regulation.
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