OWR — Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery Class II
FDA product code OWR covers "Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OWR
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
For reinforcement of soft tissue where weakness exists in facial plastic surgery.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201153 | shanghai suokang medical implants co | Tisuthes e-PTFE Surgical Patch | June 13, 2023 |