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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K071381
Device Name GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
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 Number892.5700
Classification Product Code
JAQ  
Date Received05/17/2007
Decision Date 07/18/2007
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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