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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 K152095
Device Name Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)
Applicant
Cosmedico Light, Inc.
233 Libbey Industrial Pkwy.
Weymouth,  MA  02189
Applicant Contact STEVEN SCHLITT
Correspondent
Cosmedico Light, Inc.
233 Libbey Industrial Pkwy.
Weymouth,  MA  02189
Correspondent Contact STEVEN SCHLITT
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received07/28/2015
Decision Date 10/28/2015
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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