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
- N
Related Records
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
- 3027616027