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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 K151370
Device Name UV Lamps for Indoor Tanning Devices
Applicant
Light Sources, Inc.
37 Robinson Blvd.
Orange,  CT  06477
Applicant Contact EUGENE CZAKO
Correspondent
Light Sources, Inc.
37 Robinson Blvd.
Orange,  CT  06477
Correspondent Contact Susan Anthony
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received05/21/2015
Decision Date 12/17/2015
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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