Simulatan (Including Crossed Cylinder)
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Jiangsu: 2 hold an FDA registration.
- Lianyungang Tiannuo Optical Instrument Co., Ltd. Jiangsu, contract manufacturer
- Taizhou City K&W International Trade Co., Ltd. Jiangsu
What Is FDA Product Code HOR?
Simulatan (Including Crossed Cylinder) is FDA product code HOR, Class 1, 21 CFR 886.1840.
How Does It Reach the US Market?
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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