FDA 510(k) Application Details - K151905

Device Classification Name Booth, Sun Tan

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510(K) Number K151905
Device Name Booth, Sun Tan
Applicant HEARTLAND TANNING, INC.
4251 NE Port Dr.
Lees Summit, MO 64064 US
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Contact Jon Marcum
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 07/13/2015
Decision Date 03/01/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K151905


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