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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
510(k) Number K201153
Device Name Tisuthes e-PTFE Surgical Patch
Applicant
Shanghai Suokang Medical Implants Co., Ltd.
Bldg. 2, # 613, Suide Rd., Putuo Region, Shanghai,
200311, P.R. China
Shanghai,  CN 200000
Applicant Contact Lixinhua Lixinhua
Correspondent
Shanghai Suokang Medical Implants Co., Ltd.
Bldg. 2, # 613, Suide Rd., Putuo Region, Shanghai,
200311, P.R. China
Shanghai,  CN 200000
Correspondent Contact Lixinhua Lixinhua
Regulation Number878.3300
Classification Product Code
OWR  
Subsequent Product Code
FTL  
Date Received04/30/2020
Decision Date 06/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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