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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 K033732
Device Name MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450
Applicant
Medtrade Products , Ltd.
Electra House
Crewe Business Park Crewe
Cheshire,  GB CW1 6GL
Applicant Contact JONATHAN D RANFIELD
Correspondent
Medtrade Products , Ltd.
Electra House
Crewe Business Park Crewe
Cheshire,  GB CW1 6GL
Correspondent Contact JONATHAN D RANFIELD
Classification Product Code
FRO  
Date Received11/28/2003
Decision Date 12/01/2004
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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