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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 K171645
Device Name CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
Applicant
Strukmyer Medical
1801 Big Town Blvd.
Suite 100
Mesquite,  TX  75149
Applicant Contact Pamela Liberto
Correspondent
Strukmyer Medical
1801 Big Town Blvd.
Suite 100
Mesquite,  TX  75149
Correspondent Contact Pamela Liberto
Classification Product Code
KGN  
Date Received06/05/2017
Decision Date 07/25/2017
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
Recalls CDRH Recalls
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