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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 K151721
Device Name FIJI SUN FLUORESCENT TANNING UNIT
Applicant
Kdb Inc. (Dba) Sperti Sunlamp
2550 American Court
Crescent Springs,  KY  41017
Applicant Contact JAMES SHEPERD
Correspondent
Kdb Inc. (Dba) Sperti Sunlamp
2424 Dempster Dr.
Coralville,  IA  52241
Correspondent Contact Susan R Anthoney
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received06/25/2015
Decision Date 06/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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