510(k) K201996
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2020
- Date Received
- July 20, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type