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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 K852534
Device Name ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9
Applicant
R. A. FISCHER CO. CORP.
517 COMMERCIAL ST.
GLENDALE,  CA  91203
Applicant Contact VAN ORDEN
Correspondent
R. A. FISCHER CO. CORP.
517 COMMERCIAL ST.
GLENDALE,  CA  91203
Correspondent Contact VAN ORDEN
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/14/1985
Decision Date 11/08/1985
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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