FDA 510(k) Application Details - K152452

Device Classification Name Booth, Sun Tan

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510(K) Number K152452
Device Name Booth, Sun Tan
Applicant MEDTEK LIGHTING CORP D/B/A PEACOCK TANNING
3 DEPOT STREET
HUDSON FALLS, NY 12839 US
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Contact GARY RICHARDSON
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 08/28/2015
Decision Date 05/19/2016
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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