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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
Recalls CDRH Recalls
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