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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 K904124
Device Name PHILIPS MULTILEAF COLLIMATOR (MLC)
Original Applicant
PHILIPS MEDICAL SYSTEMS, INC.
veenpluis 4-6
p.o. box 10000
5680 da best,  NL
Original Contact william g mcmahon
Regulation Number892.5710
Classification Product Code
IXI  
Date Received09/06/1990
Decision Date 01/30/1991
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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