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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
Device Name CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING
Applicant
Medtrade Products , Ltd.
Electra House
Crewe Business Park Crewe
Cheshire,  GB CW1 6GL
Applicant Contact CLAIRE RYAN
Correspondent
Medtrade Products , Ltd.
Electra House
Crewe Business Park Crewe
Cheshire,  GB CW1 6GL
Correspondent Contact CLAIRE RYAN
Classification Product Code
FRO  
Date Received03/27/2012
Decision Date 10/26/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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