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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 K152405
Device Name IBL 5000 Tanning Booth
Applicant
Ibl Acquisitions, LLC
2653 Tobey Dr.
Indianapolis,  IN  46219
Applicant Contact MICHAEL GILLEY
Correspondent
Bender & Bender Project Management Services, LLC
3678 Gould Dr.
Carmel,  IN  46033
Correspondent Contact GREG BENDER
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received08/25/2015
Decision Date 09/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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