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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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atricure bipolar system ATRICURE, INC. k043579 07/05/2007
cuticover skin barrier device D & D HOLDINGS, LLC k042955 06/19/2006
spine-fix biomimetic bone cement TEKNIMED SA k043593 03/17/2006
sucralfate and carafate paste kits PATRICK D. MCGRATH PH.D k043587 02/03/2006
lifepak, model 1000 MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. k042404 12/22/2005
fc 700 fetal monitor BIONET CO., LTD. k043597 12/16/2005
fc 1400 fetal monitor BIONET CO., LTD. k043598 12/16/2005
newgel and newgel plus e NEWMEDICAL TECHNOLOGY, INC. k041704 10/17/2005
stingray epidural catheter connector EPIMED INTERNATIONAL, INC. k051171 08/26/2005
depuy asr modular acetabular cup system DEPUY ORTHOPAEDICS, INC. k040627 08/05/2005

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