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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
Date
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sis facial cylinder, sis facial implant COOK BIOTECH, INC. k070738 04/05/2007
rii infrared ear thermometer, model th01bn RADIANT INNOVATION INC. k070976 04/20/2007
urostym biofeedback and stimulation device and accessories LABORIE MEDICAL TECHNOLOGIES k070331 05/04/2007
procera bridge zirconia 9 units-14 units, models 30-4004 to 30-4013 NOBEL BIOCARE AB k071182 07/11/2007
aloka ssd-alpha 7 ultrasound system ALOKA CO., LTD. k072285 08/30/2007
visions pv 8.2 intravascular ultrasound imaging catheter, model 88900 VOLCANO CORPORATION k071660 08/31/2007
hemicap patello-femoral resurfacing system ARTHROSURFACE, INC. k071413 11/09/2007
ge echopac GENERAL ELECTRIC CO. k072952 11/16/2007
twin-pass otw catheter, model 5201 VASCULAR SOLUTIONS, INC. k072618 11/21/2007
modification to vertex reconstruction system MEDTRONIC SOFAMOR DANEK k071942 12/11/2007

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