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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 K922963
Device Name TL100W/12
Applicant
Philips Lighting Co.
200 Franklin Sq. Dr.
Somerset,  NJ  08875
Applicant Contact TONI J HONKISZ
Correspondent
Philips Lighting Co.
200 Franklin Sq. Dr.
Somerset,  NJ  08875
Correspondent Contact TONI J HONKISZ
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/19/1992
Decision Date 09/02/1992
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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