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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K854609
Device Name MEVAMATIC 3
Applicant
Siemens Medical Laboratories, Inc.
2404 N. Main St.
Walnut Creek,  CA  94596
Applicant Contact NICOL
Correspondent
Siemens Medical Laboratories, Inc.
2404 N. Main St.
Walnut Creek,  CA  94596
Correspondent Contact NICOL
Regulation Number892.5900
Classification Product Code
JAD  
Date Received11/18/1985
Decision Date 02/21/1986
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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