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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 K941118
Device Name HEAD IMMOBILIZATION APPARATUS
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 Received03/07/1994
Decision Date 08/25/1995
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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