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FDA Product Code

FDA Product Code OWR — Clearance Directory

Device Class
Class II
21 CFR Citation
878.3300

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
K201153 Tisuthes e-PTFE Surgical Patch Shanghai Suokang Medical Implants Co., Ltd. 2023-06-13 Traditional PDF ↗

Product code OWR · Class II · General, Plastic Surgery. Data: openFDA.