FDA 510(k) Application Details - K014036

Device Classification Name Elastomer, Silicone, For Scar Management

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510(K) Number K014036
Device Name Elastomer, Silicone, For Scar Management
Applicant MEDTRADE PRODUCTS LTD.
ELECTRA HOUSE
CREWE BUSINESS PARK
CREWE, CHESHIRE CW1 6GL CW1 6GL GB
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Contact JONATHAN D RANFIELD
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Regulation Number 878.4025

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Classification Product Code MDA
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Date Received 12/07/2001
Decision Date 02/14/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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