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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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510(K)
Number
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Decision
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5.0mm spinal screws ORTHOTEC, L.L.C. k994288 04/10/2000
7250 (megas) BIOSOUND ESAOTE, INC. k994369 02/24/2000
8fr turbo booster, guide catheter, 7fr turbo booster, model 518-063, 518-043 SPECTRANETICS CORP. k071226 06/29/2007
a-dec/w&h electric motor, model ea-50lt A-DEC, INC. k032572 12/03/2003
a.b. dental devices A.B. DENTAL DEVICES, LTD. k051719 03/21/2006
abl 77 ph, blood gas and electrolyte analysis system SENDX MEDICAL, INC. k994346 02/01/2000
abl90 flex RADIOMETER MEDICAL APS k123748 05/07/2013
abx pentra creatinine 120 cp; abx pentra multical; abx pentra n control; abx pentra p control; abx pentra urine control HORIBA ABX S.A.S. k110530 04/30/2012
access ck-mb on the access immunoassay analyzer, models 33300, 33305, 33309, 33306 BECKMAN COULTER, INC. k994439 01/14/2000
access ostase immunoenzymetric assay BECKMAN COULTER, INC. k994278 03/28/2000

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