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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 K030609
Device Name MODULEAF
Applicant
MRC SYSTEMS GMBH
HANS-BUNTE-STR. 10
HEIDELBERG,  DE D-69123
Applicant Contact JOERG STEIN
Correspondent
MRC SYSTEMS GMBH
HANS-BUNTE-STR. 10
HEIDELBERG,  DE D-69123
Correspondent Contact JOERG STEIN
Regulation Number892.5710
Classification Product Code
IXI  
Date Received02/26/2003
Decision Date 03/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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