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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 K231614
Device Name MiroTract Wound Matrix
Applicant
Reprise Biomedical, Inc.
17400 Medina Rd.
Suite 100
Plymouth,  MN  55447
Applicant Contact Powers Carrie
Correspondent
DuVal & Associates, P.A.
1820 Medical Arts Bldg.
Suite 1820
Minneapolis,  MN  55402
Correspondent Contact Herzog Kathy
Classification Product Code
KGN  
Date Received06/02/2023
Decision Date 12/13/2023
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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