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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 K960293
Device Name MRTOFLM COMPUTER PROGRAM
Applicant
Northwest Medical Physics Equipment, Inc.
Roentgen Hall
21031 67th Ave. W.
Lynnwood,  WA  98036
Applicant Contact DOUGLAS JONES
Correspondent
Northwest Medical Physics Equipment, Inc.
Roentgen Hall
21031 67th Ave. W.
Lynnwood,  WA  98036
Correspondent Contact DOUGLAS JONES
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/16/1996
Decision Date 08/01/1996
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
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