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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 K152452
Device Name Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
Applicant
Medtek Lighting Corp D/B/A Peacock Tanning
3 Depot St.
Hudson,  NY  12839
Applicant Contact GARY RICHARDSON
Correspondent
Aegis Regulatory, Inc.
2424 Dempster Dr.
Coralville,  IA  52241
Correspondent Contact SUSAN ANTHONEY-DEWET
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received08/28/2015
Decision Date 05/19/2016
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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