FDA 510(k) Application Details - K152412

Device Classification Name Booth, Sun Tan

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510(K) Number K152412
Device Name Booth, Sun Tan
Applicant Tanses Technologies inc.
4450 Highway 13
Fabreville H7R 6E9 CA
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Contact Kirk Kiremitci
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 08/26/2015
Decision Date 04/29/2016
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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