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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 K253665
Device Name Vashe Plus Antimicrobial Solution
Applicant
Urgo Medical North America, LLC
100 Lexington St.
Suite 400
Fort Worth,  TX  76102
Applicant Contact Steven Dowdley
Correspondent
Urgo Medical North America, LLC
100 Lexington St.
Suite 400
Fort Worth,  TX  76102
Correspondent Contact Steven Dowdley
Classification Product Code
FRO  
Date Received11/21/2025
Decision Date 08/11/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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