510(k) K091499
K091499 is an FDA 510(k) premarket notification submitted by Kensey Nash Corp. for the device "MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)". The FDA issued a decision of Substantially Equivalent on October 22, 2009. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Kensey Nash Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2009
- Date Received
- May 21, 2009
- 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