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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
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affinity vard sub-assembly for cps (carmeda coated), purgeline (uncoated), holding bag MEDTRONIC PERFUSION SYSTEMS k101186 09/03/2010
attain command 6250 left heart delivery systems and attain command 6250 guide catheters for left heart delivery MEDTRONIC INC. k080428 12/09/2008
cardioblate maps surgical mapping, ablation, pacing , and sensing device MEDTRONIC INC. k121451 06/14/2012
medline strider maxi 4 MEDLINE INDUSTRIES, INC. k041055 05/25/2004
bioflex ld-r100 treatment head MEDITECH INTERNATIONAL, INC. k081355 12/18/2008
reverso MEDISYSTEMS CORP. k994306 03/20/2000
mri- flow analytical software package MEDIS MEDICAL IMAGING SYSTEMS, B.V. k994282 03/02/2000
mri- magnetic resonance analytical software system MEDIS MEDICAL IMAGING SYSTEMS, B.V. k994283 08/30/2000
easy care and tubing sets MEDIONICS INTERNATIONAL, INC. k994218 02/10/2000
cmap pro MEDICAL TECHNOLOGIES, INC. k113074 02/02/2012

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