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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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amigo insulin pump NIPRO DIABETES SYSTEMS, INC. k050312 05/09/2005
amplatzer sizing balloon ii AGA MEDICAL CORP. k053440 12/30/2005
aneroid sphygmanometer with stethoscope, model hs-50a SHANGHAI LORD INTERNATIONAL TRADE CO., LTD. k051021 06/20/2005
angiodynamics, inc., micro access kits ANGIODYNAMICS, INC. k051655 09/12/2005
apex modular alumina femoral head APEX SURGICAL, LLC. k012918 11/27/2001
aquinox SMITHS MEDICAL ASD, INC. k050314 02/18/2005
arctec semirigid plating system ALTIVA CORP. k051044 10/07/2005
artelon surgical suture ARTIMPLANT AB k052482 10/17/2005
arthrex fingershield finger guard, model ar-7199-xx ARTHREX, INC. k052387 11/29/2005
arthrocare perc-d spinewand ARTHROCARE CORP. k053447 12/27/2005

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