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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
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verify sirius biological indicator challenge pack Steris Corporation k073618 01/07/2009
ster-mate sterile lavage kit Dentsply Interntional k082973 01/29/2009
modification to: halo coagulation catheter, models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 Barrx Medical, Incorporated k083711 02/02/2009
hydrorise and hydrosystem Zhermack S.P.A. k083739 03/26/2009
extreme 4x4-x8 power wheelchair Vestil Manufacturing Corp. k090350 04/10/2009
sensititre yeastone susceptibility plates Trek Diagnostic Systems, Inc. k090968 06/04/2009
silk black braided surgical sutures, nylon monofilament blue and black surgical sutures Supplidores Unidos Internacionales, S.A. k091574 10/09/2009
estech easyflow cannula with guidewire Endoscopic Technologies, Inc. D/B/A Estech k091542 10/20/2009
smartpill gi monitoring system, version 2.0 The Smartpill Corporation k092342 10/30/2009
powder-free vinyl patient examination gloves Tangshan Excellence Glove Co., Ltd. k093270 11/04/2009

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