510(k) K091499

MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) by Kensey Nash Corp. — Product Code FTM

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