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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 K223257
Device Name Miro3D Wound Matrix
Applicant
Reprise Biomedical
17400 Medina Rd.
Plymouth,  MN  55447
Applicant Contact Carrie Powers
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Kathy Herzog
Classification Product Code
KGN  
Date Received10/21/2022
Decision Date 11/21/2022
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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