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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accelerator, linear, medical
510(k) Number K904364
Device Name VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C
Applicant
VARIAN ASSOC., INC.
611 HANSEN WAY
P.O. BOX 10800
PALO ALTO,  CA  94303
Applicant Contact CHARLES WILL
Correspondent
VARIAN ASSOC., INC.
611 HANSEN WAY
P.O. BOX 10800
PALO ALTO,  CA  94303
Correspondent Contact CHARLES WILL
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/24/1990
Decision Date 02/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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