510(k) K182476
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2019
- Date Received
- September 10, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type