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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K992751
Device Name SOMAVISION
Applicant
Varian Assoc., Inc.
3045 Hanover St.
Palo Alto,  CA  94304 -1129
Applicant Contact LINDA S NASH
Correspondent
Varian Assoc., Inc.
3045 Hanover St.
Palo Alto,  CA  94304 -1129
Correspondent Contact LINDA S NASH
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received08/16/1999
Decision Date 02/16/2000
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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