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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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datex-ohmeda oxygen saturation module, m-osat and accessoires Datex-Ohmeda., Inc. k010463 03/15/2001
denstat Elmed, Inc. k010465 05/14/2001
denver pak w/ double-valve ascites shunt,denver pak w/ single-valved ascites shunt, denver pak, doubled-valved ascites t Denver Biomedicals, Inc. k003451 01/02/2001
diagnostic electromyography needle electrode, disposable hypodermic needle Medicotest A/S k001869 09/18/2000
dialysis delivery sys., ultim. model ii Vital Systems, Inc. k770350 03/08/1977
dialysis, jet system Janneck Ent. OF Texas k770331 04/20/1977
diamedix is-rubella igm capture test system Diamedix Corp. k001875 08/21/2000
diatek cannon-cath #cc2400, cc2800, cc3200, cc3600,cc5500. cc2400pc, cc2800pc, cc3200pc(32 cm), cc3200pc(36 cm) Diatek, Inc. k010399 08/14/2001
digi trol tm-rx & digi trol tm-tx Nuclear Medical Laboratories, Inc. k770411 03/16/1977
digimam digital stereotactic biopsy system option for glory mammographic system Elscintec Systems , Ltd. k003473 11/28/2000

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