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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K141738
Device Name MEDEOR MATRIX WOUND DRESSING
Applicant
Kensey Nash Corporation Dba Dsm Biomedical
735 Pennsylvania Dr.
Exton,  PA  19341
Applicant Contact BRIANNA JORDAN
Correspondent
Kensey Nash Corporation Dba Dsm Biomedical
735 Pennsylvania Dr.
Exton,  PA  19341
Correspondent Contact BRIANNA JORDAN
Classification Product Code
KGN  
Date Received06/27/2014
Decision Date 02/17/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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