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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 K173565
Device Name Sunrise 6200, Sunrise 7200
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 Received11/17/2017
Decision Date 02/14/2018
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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