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510(k) K201153

Device
Tisuthes e-PTFE Surgical Patch
Applicant
Shanghai Suokang Medical Implants Co., Ltd.
510(k) number
K201153
Product code
OWR
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-13
Date received
2020-04-30
Regulation
878.3300
Classification name
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lixinhua Lixinhua
Address
Bldg. 2, # 613, Suide Rd., Putuo Region, Shanghai, 200311, P.R. China Shanghai CN 200000 200000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF