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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nursing Pad, Hydrogel
510(k) Number K030901
Device Name MEDTRADE PRODICT'S SOOTHING GEL PATCH
Applicant
Medtrade Products , Ltd.
Electra House
Crewe Business Park Crewe
Cheshire,  GB CW1 6GL
Applicant Contact JONATHAN RANFIELD
Correspondent
Medtrade Products , Ltd.
Electra House
Crewe Business Park Crewe
Cheshire,  GB CW1 6GL
Correspondent Contact JONATHAN RANFIELD
Regulation Number880.5630
Classification Product Code
NTC  
Date Received03/24/2003
Decision Date 11/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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