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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 K260530
Device Name epi-ConneKt™ Wound Matrix
Applicant
MLM Biologics, Inc.
13700 Progress Blvd.
Alachua,  FL  32615
Applicant Contact Travis Arola
Correspondent
MLM Biologics, Inc.
13700 Progress Blvd.
Alachua,  FL  32615
Correspondent Contact Travis Arola
Classification Product Code
KGN  
Date Received02/17/2026
Decision Date 10/15/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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