Corneal Inlay Inserter Handle
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Jiangsu: 2 hold an FDA registration. 1 is a contract manufacturer.
- Belle Healthcare Technology Co., Ltd. Jiangsu
- Malosa Medical Instruments (Changshu) Limited Jiangsu, contract manufacturer
What Is This Device?
The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
What Is FDA Product Code QGJ?
Corneal Inlay Inserter Handle is FDA product code QGJ, Class 1, 21 CFR 886.4355.
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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