FDA 510(k) Application Details - K991970

Device Classification Name Elastomer, Silicone, For Scar Management

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510(K) Number K991970
Device Name Elastomer, Silicone, For Scar Management
Applicant PILLAR SURGICAL
PO BOX 8141
LA JOLLA, CA 92038 US
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Contact ROB FRITZENKOTTER
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Regulation Number 878.4025

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Classification Product Code MDA
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Date Received 06/11/1999
Decision Date 10/25/1999
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



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