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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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select 3d arterial cannula with carmeda bioactive surface and select cap arterial cannula with carmeda bioactive surface Medtronic Perfusion Systems k033416 11/05/2003
tripter x-1 compact Direx Systems Corp. k040470 04/28/2004
lysus infusion system Ekos Corp. k041629 08/06/2004
laserex, model lp4532 Ellex Medical Pty, Ltd. k041598 10/06/2004
duet suture anchor, models bxs4216, bxs4216h; impact suture anchor, models bxs4218, bxs4218h Linvatec Biomaterials, Ltd. k042966 11/19/2004
zygoma tiunite Nobel Biocare USA, LLC k050641 04/07/2005
estelite flow quick Tokuyama Dental Corporation k051808 08/08/2005
smartsite vented vial access device, model tbd Cardinal Health, Alaris Products k052790 12/23/2005
braun thermoscan irt 2000 infrared ear thermometer Braun GmbH k060006 01/31/2006
juliesse injectable laryngeal augmentation implant Bioform Medical, Inc. k060815 04/18/2006

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