Melting Pot, Paraffin
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu.
What Is FDA Product Code IDS?
Melting Pot, Paraffin is FDA product code IDS, Class 1, 21 CFR 864.3010.
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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