Tisuthes
Tisuthes e-PTFE Surgical Patches are intended for facial plastic and reconstructive surgery. The filing lists sheet, block and preformed three-dimensional forms, including chin, nasal,…
Mesh, Surgical, Non-Absorbable, Facial Implants for Plastic Surgery
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Shanghai.
What Is This Device?
For reinforcement of soft tissue where weakness exists in facial plastic surgery.
What Is FDA Product Code OWR?
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery is FDA product code OWR, Class 2, 21 CFR 878.3300.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 1,139 days from receipt to decision.
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