510(k) K213125
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2021
- Date Received
- September 27, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type