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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 K120930
Model VARIOUS SIZES
Device Name CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING
Original Applicant
MEDTRADE PRODUCTS LTD.
electra house
crewe business park crewe
cheshire,  UK cw1 6gl
Original Contact claire ryan
Classification Product Code
FRO  
Date Received03/28/2012
Decision Date 10/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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