FDA 510(k) Application Details - K152336

Device Classification Name Booth, Sun Tan

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510(K) Number K152336
Device Name Booth, Sun Tan
Applicant J & B PRODUCTS LTD DBA HEX TANNING
2201 S MICHIGAN AVENUE
SAGINAW, MI 48602 US
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Contact LINDA BOMMARITO
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 08/19/2015
Decision Date 05/02/2016
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



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