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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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fluorilaq PASCAL CO., INC. k030488 05/02/2003
cozart eia cotinine urine kit COZART BIOSCIENCE LTD. k021944 05/14/2003
bio-modular shoulder system BIOMET, INC. k030710 06/04/2003
rusch guided cholangiography catheter RUSCH INTL. k023666 06/17/2003
edwards lifesciences percutaneous sheath introducers with oligon material EDWARDS LIFESCIENCES, LLC. k030944 06/20/2003
asyra GALLOWAY TECHNOLOGIES, LLC k023355 06/24/2003
lordex power traction equipment EVER PROSPEROUS INSTRUMENT INC k031227 07/17/2003
radius 018 cougar wire RADIUS MEDICAL TECHNOLOGIES, INC. k032129 07/17/2003
biosign ssi biological test pack with instant readout integrator GETINGE USA, INC k031647 07/29/2003
microlife instant digital electronic thermometer, model qt1ja1 MICROLIFE INTELLECTUAL PROPERTY GMBH k031958 08/15/2003

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