Tisuthes e-PTFE Surgical Patch— 510(k) K201153

Substantially Equivalent

Shanghai Suokang Medical Implants Co., Ltd.

FDA 510(k) clearance K201153 for Tisuthes e-PTFE Surgical Patch, Substantially Equivalent on 2023-06-13. Applicant: Shanghai Suokang Medical Implants Co., Ltd..

Clearance details

Applicant: Shanghai Suokang Medical Implants Co., Ltd.
Product code: Code OWR
Advisory panel: General, Plastic Surgery
Date received: 2020-04-30
Decision date: 2023-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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