Unit, Electrolysis, Battery-Powered, Ophthalmic
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong.
- Ever Strong Manufacturing Ltd Guangdong, contract manufacturer
What Is FDA Product Code HPY?
Unit, Electrolysis, Battery-Powered, Ophthalmic is FDA product code HPY, Class 1, 21 CFR 886.4250.
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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