FDA 510(k) Application Details - K152332

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K152332
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant OMM IMPORTS INC DBA ZERO GRAVITY
1945 S OCEAN DR APT 509 HALLANDLE BEACH BLVD
HALLANDLE, FL 33009 US
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Contact OHAD MENACHEM
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 08/18/2015
Decision Date 02/25/2016
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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