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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
Date
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etest gatifloxacin AB BIODISK k000596 05/22/2000
vita response VIDENT k000597 05/17/2000
5f guiding catheter GUIDANT CORP. k000598 03/24/2000
vitalograph base station VITALOGRAPH, INC. k000599 09/08/2000
syva emit 2000 thyroxine assay, calibrators SYVA CO., DADE BEHRING, INC. k000600 03/27/2000
ems jumper ii dual channel neuromuscular stimulator system, model e-188 138 MEDICAL SUPPLIES, INC. k000741 10/24/2001
synthes anterior cslp system SYNTHES SPINE k000742 03/29/2000
boston scientific scimed atlantis coronary imaging catheter, model c4020 BOSTON SCIENTIFIC SCIMED, INC. k000743 09/06/2000
medtronic ave bridge x3 stent MEDTRONIC AVE, INC. k000744 06/05/2000
sensi grip latex examination glove, powdered contains 200 mcgm or less of total water extractable protein per gram TILLOTSON HEALTHCARE CORP. k000745 05/03/2000

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