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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
Date
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innoject auto-injector INNOJECT, INC k042557 11/08/2004
multi chem cal b WAKO CHEMICALS, USA, INC. k042549 11/08/2004
multi-lipid calibrator WAKO CHEMICALS, USA, INC. k042550 11/08/2004
vasc-alert VASC-ALERT, INC. k042566 11/08/2004
k.e.p. connector and clip K.E.P., LLC k042900 11/05/2004
kendall co2nfirm now co2 detector KENDALL k042572 11/05/2004
mas, dade and liquid assayed diabetes control MEDICAL ANALYSIS SYSTEMS, INC. k042717 11/05/2004
zimmer m/l taper hip prosthesis with calcicoat ceramic coating ZIMMER, INC. k042337 11/04/2004
neo-clip orthodontic bracket accessory DENTSPLY INTL. k042905 11/04/2004
best breast brachytherapy applicator BEST MEDICAL INTERNATIONAL, INC. k042586 11/03/2004

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