510(k) K212594
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2022
- Date Received
- August 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Absorbable
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type