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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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model 4000 eeg monitor with psi (psa4000) PHYSIOMETRIX, INC. k001069 06/30/2000
bioz.pc hemodynamic monitor model bz-500/bz-501; bioz.pc user software installation kit model bz-810 CARDIODYNAMICS INTERNATIONAL CORP. k001081 06/30/2000
performer 30 hps CORNELIA DAMSKY, INC. k001322 06/30/2000
synthetic powder free (yellow) vinyl patient examination gloves SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD. k001834 06/30/2000
daniels sharpsmart reusable sharps container THE DANIELS CORP. k001337 07/05/2000
mallinckrodt, goodknight 418s MALLINCKRODT DEVELOPPEMENT FRANCE k001845 07/05/2000
hitachi airis ii HITACHI MEDICAL SYSTEMS AMERICA, INC. k001334 07/06/2000
swan-ganz synthetic controlcath thermodilution catheters, models c146f7, c146hf7, s146f7, s146hf7 BAXTER HEALTHCARE CORP. k001063 07/07/2000
sulzer orthopedics inc. natural-hip system ld stem SULZER ORTHOPEDICS, INC. k001320 07/07/2000
the v-bag CIRCULATORY TECHNOLOGY, INC. k001822 07/07/2000

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