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510(k) K170754

3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing by 3M Company, 3M Healthcare — Product Code FRO

K170754 is an FDA 510(k) premarket notification submitted by 3M Company, 3M Healthcare for the device "3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing". The FDA issued a decision of Substantially Equivalent on Nov 21, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 21, 2017
Date Received
Mar 13, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

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FDA data resources