FDA 510(k) Application Details - K173565

Device Classification Name Booth, Sun Tan

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510(K) Number K173565
Device Name Booth, Sun Tan
Applicant JK-Holding GmbH
Koehlershohner Strasse 60
Windhagen 53578 DE
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Contact Juergen Gerstenmeier
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 11/17/2017
Decision Date 02/14/2018
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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