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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 K151400
Device Name Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
Applicant
Jk Holding GmbH
Koehlershohner Strasse 60
Windhagen,  DE 53578
Applicant Contact JUERGEN GERSTENMEIER
Correspondent
Jk Holding GmbH
Koehlershohner Strasse 60
Windhagen,  DE 53578
Correspondent Contact JUERGEN GERSTENMEIER
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received05/26/2015
Decision Date 09/16/2015
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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