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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 K152141
Device Name High Pressure Tanning Lamps
Applicant
Blv Licht-Und Vakuumtechnik GmbH
Munchener Strasse 10
Steinhoring,  DE 85643
Applicant Contact Heinz-Jurgen Wesseling
Correspondent
Blv Licht-Und Vakuumtechnik GmbH
Munchener Strasse 10
Steinhoring,  DE 85643
Correspondent Contact Heinz-Jurgen Wesseling
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received08/03/2015
Decision Date 02/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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