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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone, For Scar Management
510(k) Number K014036
Device Name MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.
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 Number878.4025
Classification Product Code
MDA  
Date Received12/07/2001
Decision Date 02/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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