Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
The Mesh, Surgical, Non-Absorbable, Facial Implants for Plastic Surgery is a surgical implant used for reinforcement of soft tissue where weakness exists in facial plastic surgery procedures. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWR, with regulation number 878.3300 under the General, Plastic Surgery medical specialty, and it carries an implant flag.
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Basic Information
- Product Code
- OWR
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
For reinforcement of soft tissue where weakness exists in facial plastic surgery.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201153 | Tisuthes e-PTFE Surgical Patch | Jun 13, 2023 | Substantially Equivalent | Shanghai Suokang Medical Implants Co., Ltd. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.