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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 K240753
Device Name Miro3D Fibers Wound Matrix
Applicant
Reprise Biomedical, Inc.
17400 Medina Rd.
Suite 100
Plymouth,  MN  55447
Applicant Contact Erin Badali
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 Received03/20/2024
Decision Date 04/19/2024
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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