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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 K812032
Device Name MEVATRON 67E
Applicant
Siemens Medical Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Siemens Medical Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/20/1981
Decision Date 08/18/1981
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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