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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 K251866
Device Name Tegaderm Post-Op Transparent Antimicrobial Dressing
Applicant
Solventum US, LLC
12930 Ih 10 W.
San Antonio,  TX  78249
Applicant Contact Jamie Thomas
Correspondent
Solventum US, LLC
12930 Ih 10 W.
San Antonio,  TX  78249
Correspondent Contact Jamie Thomas
Classification Product Code
FRO  
Date Received06/17/2025
Decision Date 10/10/2025
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		 Yes
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