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.
Device ID | K151721 |
510k Number | K151721 |
Device Name: | FIJI SUN FLUORESCENT TANNING UNIT |
Classification | Booth, Sun Tan |
Applicant | KDB INC. (DBA) SPERTI SUNLAMP 2550 AMERICAN COURT Crescent Springs, KY 41017 |
Contact | James Sheperd |
Correspondent | Susan R Anthoney KDB INC. (DBA) SPERTI SUNLAMP 2424 Dempster Dr. Coralville, IA 52241 |
Product Code | LEJ |
CFR Regulation Number | 878.4635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-25 |
Decision Date | 2018-06-22 |
Summary: | summary |