FDA 510(k) Application Details - K221523

Device Classification Name Booth, Sun Tan

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510(K) Number K221523
Device Name Booth, Sun Tan
Applicant Unilam Co., Ltd.
23 Samdong-Ro, Samnam-Myeon, Ulju-Gun, Ulsan
Ulsan Gwangyeogsi 44954 KR
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Contact Y B Cho
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 05/26/2022
Decision Date 02/15/2023
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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