FDA 510(k) Application Details - K152405

Device Classification Name Booth, Sun Tan

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510(K) Number K152405
Device Name Booth, Sun Tan
Applicant IBL ACQUISITIONS LLC
2653 TOBEY DRIVE
INDIANAPOLIS, IN 46219 US
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Contact MICHAEL GILLEY
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 08/25/2015
Decision Date 09/01/2016
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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