FDA 510(k) Application Details - K201153

Device Classification Name	More FDA Info for this Device
510(K) Number	K201153
Device Name	Tisuthes e-PTFE Surgical Patch
Applicant	Shanghai Suokang Medical Implants Co., Ltd. Building 2, No. 613, Suide Rd., Putuo Region, Shanghai, 200311, P.R. China Shanghai 200000 CN Other 510(k) Applications for this Company
Contact	Lixinhua Lixinhua Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2020
Decision Date	06/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review