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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 K253140
Device Name CollOvine™ Wound Powder
Applicant
Ovigenex, LLC
2630 Homestead Place
Dominguez Hills,  CA  90220
Applicant Contact Thomas Hyland
Correspondent
Ovigenex, LLC
2630 Homestead Place
Dominguez Hills,  CA  90220
Correspondent Contact Thomas Hyland
Classification Product Code
KGN  
Date Received09/25/2025
Decision Date 02/10/2026
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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