Ovens, Paraffin
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu.
How Is IDR Classified?
Ovens, Paraffin is FDA product code IDR, 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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