FDA 510(k) Application Details - K012419

Device Classification Name Elastomer, Silicone, For Scar Management

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510(K) Number K012419
Device Name Elastomer, Silicone, For Scar Management
Applicant IMPLANTECH ASSOCIATES, INC.
2064 EASTMAN AVE., UNIT 101
VENTURA, CA 93003 US
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Contact STEPHEN MEADE
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Regulation Number 878.4025

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Classification Product Code MDA
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Date Received 07/30/2001
Decision Date 10/24/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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