510(k) K132025
K132025 is an FDA 510(k) premarket notification submitted by Kensey Nash Corporation Dba Dsm Biomedical for the device "MESO BILAYER SURGICAL MESH". The FDA issued a decision of Substantially Equivalent on October 30, 2013. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Kensey Nash Corporation Dba Dsm Biomedical has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2013
- Date Received
- July 1, 2013
- Clearance Type
- Traditional
- 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