FDA 510(k) Application Details - K124064

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K124064
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant ESPANSIONE MARKETING SPA
VIA ALTOBELLI BONETTI 3A
IMOLA(BO) 40026 IT
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Contact GUIDO BONAPACE
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 12/31/2012
Decision Date 12/19/2013
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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