FDA 510(k) Application Details - K151674

Device Classification Name Booth, Sun Tan

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510(K) Number K151674
Device Name Booth, Sun Tan
Applicant G.I.E.- GESELLSCHAFT FUR LICHTTECHNISCHE ERZEUGNISSE MBH
HERZBERGSTRASSE 26
BERLIN 10365 DE
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Contact MICHAEL ANDERS
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 06/22/2015
Decision Date 10/20/2015
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

FDA Source Information for K151674


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