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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K011816
Device Name MINI MULTILEAF COLLIMATOR, MODEL KMI
Applicant
Mrc Systems GmbH
Hans-Bunte-Str. 10
Heidelberg,  DE 69123
Applicant Contact JORG STEIN
Correspondent
Mrc Systems GmbH
Hans-Bunte-Str. 10
Heidelberg,  DE 69123
Correspondent Contact JORG STEIN
Regulation Number892.5710
Classification Product Code
IXI  
Date Received06/11/2001
Decision Date 09/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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