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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 K882729
Device Name MEVATRON, M 2 CLASS
Applicant
SIEMENS MEDICAL LABORATORIES, INC.
2404 n. main st.
walnut creek,  CA  94596
Applicant Contact r. c nicol
Correspondent
SIEMENS MEDICAL LABORATORIES, INC.
2404 n. main st.
walnut creek,  CA  94596
Correspondent Contact r. c nicol
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/06/1988
Decision Date 09/19/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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