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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 K071992
Device Name HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)
Applicant
VARIAN MEDICAL SYSTEMS
3100 HANSEN WAY
M/S E-110
PALO ALTO,  CA  94304 -1129
Applicant Contact VY TRAN
Correspondent
VARIAN MEDICAL SYSTEMS
3100 HANSEN WAY
M/S E-110
PALO ALTO,  CA  94304 -1129
Correspondent Contact VY TRAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/20/2007
Decision Date 08/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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