The following data is part of a premarket notification filed by Ibl Acquisitions Llc with the FDA for Ibl 5000 Tanning Booth.
Device ID | K152405 |
510k Number | K152405 |
Device Name: | IBL 5000 Tanning Booth |
Classification | Booth, Sun Tan |
Applicant | IBL ACQUISITIONS LLC 2653 TOBEY DRIVE Indianapolis, IN 46219 |
Contact | Michael Gilley |
Correspondent | Greg Bender BENDER & BENDER PROJECT MANAGEMENT SERVICES LLC 3678 GOULD DR Carmel, IN 46033 |
Product Code | LEJ |
CFR Regulation Number | 878.4635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-25 |
Decision Date | 2016-09-01 |
Summary: | summary |