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510(k) K090345

MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL by Conseal International, Inc. — Product Code FRO

K090345 is an FDA 510(k) premarket notification submitted by Conseal International, Inc. for the device "MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL". The FDA issued a decision of Substantially Equivalent on January 7, 2010. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2010
Date Received
February 10, 2009
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