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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorbable Synthetic Wound Dressing
510(k) Number K161067
Device Name Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
Applicant
Engineered Tissue Solutions, LLC
4030 Hypoint N.
Rolla,  MO  65401
Applicant Contact Mark Borden
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington,  DC  20009
Correspondent Contact Randy Prebula
Classification Product Code
QSZ  
Date Received04/15/2016
Decision Date 09/15/2016
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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