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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 K901324
Device Name U.V. SUNLAMP 95UF-II
Applicant
Light Sources, Inc.
P.O. Box 569
410 Main St.
Ansonia,  CT  06401
Applicant Contact EUGENE CZAKO
Correspondent
Light Sources, Inc.
P.O. Box 569
410 Main St.
Ansonia,  CT  06401
Correspondent Contact EUGENE CZAKO
Regulation Number878.4630
Classification Product Code
FTC  
Date Received03/21/1990
Decision Date 04/26/1990
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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