FDA 510(k) Application Details - K152233

Device Classification Name Booth, Sun Tan

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510(K) Number K152233
Device Name Booth, Sun Tan
Applicant Sportarredo Group S.C.
Via dell' Industria 7
Gruaro 30020 IT
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Contact Stefano Iridio
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 08/07/2015
Decision Date 01/27/2016
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

FDA Source Information for K152233


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