Graft Cleaning Bowl
Graft cleaning bowl used in the cleaning of follicles removed from the donor area before they are entered into the recipient area.
Sieves, Tissue
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Shandong and Shanghai: 3 hold an FDA registration.
- Infitek Co., Ltd. Shanghai
- Labpeak Co., Ltd. Shandong
- Scitek Global Co., Ltd. Shandong
How Is IDX Classified?
Sieves, Tissue is FDA product code IDX, Class 1, 21 CFR 864.3010.
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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