IBL 5000 Tanning Booth

Booth, Sun Tan

IBL ACQUISITIONS LLC

The following data is part of a premarket notification filed by Ibl Acquisitions Llc with the FDA for Ibl 5000 Tanning Booth.

Pre-market Notification Details

Device IDK152405
510k NumberK152405
Device Name:IBL 5000 Tanning Booth
ClassificationBooth, Sun Tan
Applicant IBL ACQUISITIONS LLC 2653 TOBEY DRIVE Indianapolis,  IN  46219
ContactMichael Gilley
CorrespondentGreg Bender
BENDER & BENDER PROJECT MANAGEMENT SERVICES LLC 3678 GOULD DR Carmel,  IN  46033
Product CodeLEJ  
CFR Regulation Number878.4635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-25
Decision Date2016-09-01
Summary:summary

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