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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 K031800
Device Name SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
Applicant
SOLARC SYSTEMS, INC.
12 PARKER COURT
BARRIE, ONTARIO,  CA L4N 2A6
Applicant Contact BRUCE ELLIOTT
Correspondent
SOLARC SYSTEMS, INC.
12 PARKER COURT
BARRIE, ONTARIO,  CA L4N 2A6
Correspondent Contact BRUCE ELLIOTT
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/11/2003
Decision Date 09/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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