510(k) K141738

MEDEOR MATRIX WOUND DRESSING by Kensey Nash Corporation Dba Dsm Biomedical — Product Code KGN

K141738 is an FDA 510(k) premarket notification submitted by Kensey Nash Corporation Dba Dsm Biomedical for the device "MEDEOR MATRIX WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on February 17, 2015. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Kensey Nash Corporation Dba Dsm Biomedical has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2015
Date Received
June 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type