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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 K904908
Device Name STEREOTACTIC IRRADIATION SYSTEM
Applicant
Northwest Medical Physics Center
21031 67th Ave. W.
Lynnwood,  WA  98036
Applicant Contact ANDREW JONES
Correspondent
Northwest Medical Physics Center
21031 67th Ave. W.
Lynnwood,  WA  98036
Correspondent Contact ANDREW JONES
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/31/1990
Decision Date 06/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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