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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 K913119
Device Name VARIAN C-SERIES CLINACS (CLINAC 2300C/D)
Applicant
VARIAN ASSOC., INC.
3045 HANOVER ST.
PALO ALTO,  CA  94304 -1129
Applicant Contact CHARLES H WILL
Correspondent
VARIAN ASSOC., INC.
3045 HANOVER ST.
PALO ALTO,  CA  94304 -1129
Correspondent Contact CHARLES H WILL
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/15/1991
Decision Date 11/07/1991
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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