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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 K915426
Device Name MEDICAL SUNLAMP FOR PHOTOTHERAPY
Applicant
American Sunlight, Inc.
7455 Lorge Cir.
Huntington Beach,  CA  92647
Applicant Contact KENNETH R TORRENCE
Correspondent
American Sunlight, Inc.
7455 Lorge Cir.
Huntington Beach,  CA  92647
Correspondent Contact KENNETH R TORRENCE
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/02/1991
Decision Date 03/04/1992
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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