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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, 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
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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