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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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scipro(tm) flexible stone dislodger and retrieval set SCION CARDIOVASCULAR, INC. k001563 11/22/2000
scan lt40 (40 channels) NEURO SCAN LABS k001564 11/24/2000
steerable retrograde cardioplegia cannula with and without duraflo treatment, models srco14mib, diisrco14mib EDWARDS LIFESCIENCES, LLC. k001565 08/10/2000
advantage thc test ADVANTAGE DIAGNOSTICS CORP. k001567 06/19/2000
infinity amylase reagent (procedure no. 580/568) SIGMA DIAGNOSTICS, INC. k001569 06/26/2000
baumer femoral head BAUMER S.A. k001571 08/04/2000
neolus needle TERUMO EUROPE N.V. k001572 08/14/2000
sensititre 18-24 hours susceptibility plates TREK DIAGNOSTIC SYSTEMS, INC. k001573 07/18/2000
diastat anti-cardiolipin igg/igm, model fcar 600 AXIS-SHIELD k001574 06/09/2000
eva -vacuum assist device for clitoral therapy PROSURG, INC. k001576 12/28/2000

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