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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K254191
Device Name IWD-Gel™
Applicant
InnovaCorium, Inc.
Uf Innovate
747 SW 2nd Ave., Suite 354
Gainesville,  FL  32601
Applicant Contact Marcelo Buzzi
Correspondent
InnovaCorium, Inc.
Uf Innovate
747 SW 2nd Ave., Suite 354
Gainesville,  FL  32601
Correspondent Contact Marcelo Buzzi
Classification Product Code
FRO  
Date Received12/23/2025
Decision Date 04/07/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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