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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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510(K)
Number
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Decision
Date
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bio-fastak suture anchor, model ar-1324b Arthrex, Inc. k000506 05/01/2000
macropro gel Brennen Medical, Inc. k000518 05/01/2000
glucanpro Brennen Medical, Inc. k000519 05/01/2000
8100 vital signs monitor Criticare Systems, Inc. k001020 04/28/2000
theratron 780c/1000 with computerized console upgrade Mds Nordion k001006 04/27/2000
ascent knee revision femoral stem Biomet, Inc. k001010 04/27/2000
elecsys thyroglobulin calcheck Roche Diagnostics Corp. k001015 04/27/2000
ti500 globe-trotter transport system Hill-Rom Air-Shields k001019 04/27/2000
lilliput phospholypidic inert surface in oxygenation (ph.i.s.i.o.) infant hollow fibre oxygenator, model d902 Dideco S.P.A. k001021 04/25/2000
ge logiq 700 GE Medical Systems k001016 04/24/2000

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