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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Booth, Sun Tan
510(k) Number K143043
Device Name Tanning Lamp
Applicant
Unilam Co., Ltd.
23 Samdong-Ro, Samnam-Myeon, Ulju-Gun, Ulsan
Ulsan Gwangyeogsi,  KR 689-813
Applicant Contact YoungBoo Cho
Correspondent
Onbix Corporation
#821 Samil Plaza
837-26 Yeuksam-Dong
Gangnam-Gu,  KR
Correspondent Contact YANG HO DONG
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received10/22/2014
Decision Date 04/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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