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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 K894230
Device Name PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)
Applicant
SIEMENS MEDICAL LABORATORIES, INC.
2404 N. MAIN ST.
WALNUT CREEK,  CA  94596
Applicant Contact MORTON JR.
Correspondent
SIEMENS MEDICAL LABORATORIES, INC.
2404 N. MAIN ST.
WALNUT CREEK,  CA  94596
Correspondent Contact MORTON JR.
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/19/1989
Decision Date 08/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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