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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
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