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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 K910767
Device Name TL100W/01 UVB LAMP
Applicant
PHILIPS LIGHTING CO.
200 FRANKLIN SQUARE DR.
SOMERSET,  NJ  08875 -6800
Applicant Contact TONI J HONKISZ
Correspondent
PHILIPS LIGHTING CO.
200 FRANKLIN SQUARE DR.
SOMERSET,  NJ  08875 -6800
Correspondent Contact TONI J HONKISZ
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/22/1991
Decision Date 05/23/1991
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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