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510(k) K251866

Tegaderm Post-Op Transparent Antimicrobial Dressing by Solventum US, LLC — Product Code FRO

K251866 is an FDA 510(k) premarket notification submitted by Solventum US, LLC for the device "Tegaderm Post-Op Transparent Antimicrobial Dressing". The FDA issued a decision of Substantially Equivalent on October 10, 2025. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2025
Date Received
June 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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FDA data resources