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510(k) K201153

Tisuthes e-PTFE Surgical Patch by Shanghai Suokang Medical Implants Co., Ltd. — Product Code OWR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 13, 2023
Date Received: April 30, 2020
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
Device Class: Class II
Regulation Number: 878.3300
Review Panel: SU
Submission Type

For reinforcement of soft tissue where weakness exists in facial plastic surgery.