FDA.report

510(k) K251866

Device
Tegaderm Post-Op Transparent Antimicrobial Dressing
Applicant
Solventum US, LLC
510(k) number
K251866
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-10
Date received
2025-06-17
Classification name
Dressing, Wound, Drug
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jamie Thomas
Address
12930 Ih 10 W. San Antonio TX US 78249 78249

FDA Registration Numbers

Source Documents

510(k) summary PDF

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