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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 K260596
Device Name Collagen Wound Powder
Applicant
Ventris Medical
1201 Dove St.
Suite 470
Newport Beach,  CA  92660
Applicant Contact John Brunelle
Correspondent
Trisler Consulting, Dba
306 Turnberry Ct.
Lebanon,  IN  46053
Correspondent Contact Patsy Trisler
Classification Product Code
KGN  
Date Received02/24/2026
Decision Date 07/02/2026
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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