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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K051082
Device Name MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
Applicant
Medtrade Products , Ltd.
Electra House, Crewe Business Park
Crewe,  GB CW1 6GL
Applicant Contact JONATHAN D RANFIELD
Correspondent
Medtrade Products , Ltd.
Electra House, Crewe Business Park
Crewe,  GB CW1 6GL
Correspondent Contact JONATHAN D RANFIELD
Regulation Number880.5090
Classification Product Code
KMF  
Date Received04/27/2005
Decision Date 11/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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