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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 K151905
Device Name 3400E series; E5400 series; E6400 series; Sundazzler series
Applicant
Heartland Tanning, Inc.
4251 NE Port Dr.
Lees Summit,  MO  64064
Applicant Contact Jon Marcum
Correspondent
Heartland Tanning, Inc.
4251 NE Port Dr.
Lees Summit,  MO  64064
Correspondent Contact Jon Marcum
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received07/13/2015
Decision Date 03/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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