510(k) K093196
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2010
- Date Received
- October 9, 2009
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type