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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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