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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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modification to fetal assist Huntleigh Diagnostics , Ltd. k020390 04/19/2002
opening/closing wedge ostetomy plates Arthrex, Inc. k014155 03/18/2002
pump tubing Terumo Cardiovascular Systems Corp. k013578 01/22/2002
datacaptor Capsule Technologie k013019 12/18/2001
sureset infusion set, model 8023 Applied Diabetes Research, Incorporated k012429 11/06/2001
orthovita piston syringe or imbibe bone marrow aspiration syringe Orthovita, Inc. k011087 09/19/2001
r120 modular total hip system Osteoimplant Technology, Inc. k011774 09/05/2001
interlink threaded lock cannula Bd k011858 06/19/2001
m2376a devicelink system Agilent Technologies, Inc. k010453 03/02/2001
thromborel s Dade Behring, Inc. k003870 02/20/2001

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