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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 K190173
Device Name Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
Applicant
Jk-Holding GmbH
Koehlershohner Strabe 60
Windhagen,  DE 53578
Applicant Contact Juergen Gerstenmeier
Correspondent
Jk-Holding GmbH
Koehlershohner Strabe 60
Windhagen,  DE 53578
Correspondent Contact Juergen Gerstenmeier
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received02/01/2019
Decision Date 05/10/2019
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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