FDA 510(k) Application Details - K984213

Device Classification Name Elastomer, Silicone, For Scar Management

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510(K) Number K984213
Device Name Elastomer, Silicone, For Scar Management
Applicant CAPITAL MARKETING TECHNOLOGIES, INC.
3630 SOUTH I-35, SUITE A
WACO, TX 76706 US
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Contact JOHN SNYDER
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Regulation Number 878.4025

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Classification Product Code MDA
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Date Received 11/24/1998
Decision Date 04/14/1999
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

FDA Source Information for K984213


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