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U.S. Department of Health and Human Services

510(K) Premarket Notification

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61 to 70 of 498 Results
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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attain command 6250 left heart delivery systems and attain command 6250 guide catheters for left heart delivery MEDTRONIC INC. k080428 12/09/2008
atw marker wire steerable guidewire CORDIS CORP. k994358 01/13/2000
automated core biopsy device PROMEX, INC. k994272 01/07/2000
automated non-invasive blood pressure monitor, model bpm-100 VSM MEDTECH LTD. k994423 03/28/2000
autostat ii rheumatoid factor igm elisa COGENT DIAGNOTICS LTD. k994338 02/03/2000
axsym holo tc reagent kit, model 3l83-20; standard calibrator kit, model 3l83-01; control kit, model 3l83-10 AXIS-SHIELD DIAGNOSTICS, LTD. k062467 11/22/2006
baby face SONORA MEDICAL SYSTEMS k994385 03/16/2000
babyair PROMEDIC, INC. k060497 07/11/2006
bact/alert sv ORGANON TEKNIKA CORP. k994343 02/10/2000
bard endoscopic suturing system C.R. BARD, INC. k994290 03/20/2000

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