FIJI SUN FLUORESCENT TANNING UNIT

Booth, Sun Tan

KDB INC. (DBA) SPERTI SUNLAMP

The following data is part of a premarket notification filed by Kdb Inc. (dba) Sperti Sunlamp with the FDA for Fiji Sun Fluorescent Tanning Unit.

Pre-market Notification Details

Device IDK151721
510k NumberK151721
Device Name:FIJI SUN FLUORESCENT TANNING UNIT
ClassificationBooth, Sun Tan
Applicant KDB INC. (DBA) SPERTI SUNLAMP 2550 AMERICAN COURT Crescent Springs,  KY  41017
ContactJames Sheperd
CorrespondentSusan R Anthoney
KDB INC. (DBA) SPERTI SUNLAMP 2424 Dempster Dr. Coralville,  IA  52241
Product CodeLEJ  
CFR Regulation Number878.4635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-25
Decision Date2018-06-22
Summary:summary

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