FDA 510(k) Application Details - K143043

Device Classification Name Booth, Sun Tan

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510(K) Number K143043
Device Name Booth, Sun Tan
Applicant UNILAM CO., LTD.
23 SAMDONG-RO, SAMNAM-MYEON, ULJU-GUN, ULSAN
ULSAN GWANGYEOGSI 689-813 KR
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Contact YoungBoo Cho
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 10/22/2014
Decision Date 04/02/2015
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



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