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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 K940672
Device Name CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL
Applicant
Philips Lighting Co.
200 Franklin Sq. Dr.
P.O. Box 6800
Somerset,  NJ  08875 -6800
Applicant Contact TONI J HONKISZ
Correspondent
Philips Lighting Co.
200 Franklin Sq. Dr.
P.O. Box 6800
Somerset,  NJ  08875 -6800
Correspondent Contact TONI J HONKISZ
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received02/16/1994
Decision Date 03/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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