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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 K152423
Device Name Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy
Applicant
Sunfire Industries, Inc.
4905 Highway 70 E.
New Bern,  NC  28562
Applicant Contact Doug Tyler
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 Received08/26/2015
Decision Date 05/20/2016
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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