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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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mimix mp bone void filler BIOMET, INC. k043280 12/21/2004
cardioblate dispersive electrode adapter (accessory), model 60884 MEDTRONIC VASCULAR k043291 12/21/2004
the reliance pi process indicator, model d5116 STERIS Corporation k043482 12/21/2004
architect ca 15-3 assay FUJIREBIO DIAGNOSTICS, INC. k042732 12/22/2004
needle incapacitator (needle guard) PDMP, INC. k042907 12/22/2004
ge oec fluorostar GE OEC MEDICAL SYSTEMS, INC. k043076 12/22/2004
gore polypropylene hernia mesh W. L. GORE & ASSOCIATES, INC. k043081 12/22/2004
lysus infusion system EKOS CORP. k043269 12/22/2004
pallindrome 14.5fr chronic hemodialysis catheter with slotted symmetrical tip KENDALL k043272 12/22/2004
femspec disposable vaginal speculum FEMSPEC L.L.C. k041757 12/23/2004

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