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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K935840
Device Name TL 20W/12/RS & TL 40W/12/RS
Applicant
Philips Lighting Co.
200 Franklin Sq. Dr.
P.O. Box 6800
Somerset,  NJ  08875
Applicant Contact TONI J HONKISZ
Correspondent
Philips Lighting Co.
200 Franklin Sq. Dr.
P.O. Box 6800
Somerset,  NJ  08875
Correspondent Contact TONI J HONKISZ
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/07/1993
Decision Date 02/24/1994
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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