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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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asahi tornus support catheter with torque device accessory ASAHI INTECC CO., LTD. k060745 06/23/2006
eopa 3d arterial cannula, models 78220,78222,78320,783222 MEDTRONIC PERFUSION SYSTEMS k061254 06/23/2006
hi-torque whisper view guide wire GUIDANT CORP. k061453 06/22/2006
a & d medical um-101 digital blood pressure monitor A & D ENGINEERING, INC. k061456 06/21/2006
modular thumb implant, models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 BIOPRO, INC. k061089 06/20/2006
acumen single-lumen delivery sheath ACUMEN MEDICAL, INC. k053400 06/19/2006
3m liquid bandage 3M COMPANY k053409 06/19/2006
portex percutaneous tracheostomy kit SMITHS MEDICAL INTERNATIONAL k060945 06/19/2006
smartinfuser painpump, model p49220 w/catheter set; p49224n w/o catheter set PRECISE MEDICAL PRODUCTS, LTD. k061409 06/16/2006
vitros chemistry products tibc kit, model 886 7541; calibrator kit 4, model 120 4668 Ortho-Clinical Diagnostics, Inc. k061464 06/15/2006

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