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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K983629
Device Name RPM RESPIRATORY GATING SYSTEM
Applicant
Varian Medical Systems, Inc.
3045 Hanover St.
M/S H055
Palo Alto,  CA  94304 -1129
Applicant Contact LINDA S NASH
Correspondent
Varian Medical Systems, Inc.
3045 Hanover St.
M/S H055
Palo Alto,  CA  94304 -1129
Correspondent Contact LINDA S NASH
Regulation Number892.5050
Classification Product Code
LHN  
Subsequent Product Code
IXO  
Date Received10/15/1998
Decision Date 06/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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