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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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olympus small intestinal capsule endoscope system OLYMPUS MEDICAL SYSTEMS CORP. k123421 04/29/2013
rapidfret oral fluid assay for pcp, pcp calibrator set, pcp control set and rapidease oral fluid collector BIOPHOR DIAGNOSTICS, INC. k122703 04/25/2013
hevylite human igm kappa and hevylite igm lambda kit THE BINDING SITE GROUP LTD k113823 03/27/2013
acleara, theraclear THERAVANT CORPORATION k123889 03/04/2013
ti-max z45 NAKANISHI, INC. k121901 02/28/2013
bd phaseal closed system transfer device BECTON DICKINSON & CO. k123213 01/09/2013
delta tt cups, delta tt liners, bone screws LIMACORPORATE S.P.A. k112898 12/21/2012
powder-free vinyl patient examination gloves, clear(non-colored) YUANHANG PLASTIC CO., LTD k122835 12/10/2012
stryker universal smartlock hybrid mmf system Stryker k122313 10/31/2012
sterrad (r) cyclesure (r) 24 biological indicator ADVANCED STERILIZATION PRODUCTS k111375 09/14/2012

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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