Lens, Maddox
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu.
- Lianyungang Tiannuo Optical Instrument Co., Ltd. Jiangsu, contract manufacturer
- Taizhou City K&W International Trade Co., Ltd. Jiangsu
How Is HKR Classified?
Lens, Maddox is FDA product code HKR, Class 1, 21 CFR 886.1400.
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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