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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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hp-3, battetry operated, font wheel drive, power wheelchair TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. k011745 08/30/2001
acumatch c-series cemented femoral component, model size 0 EXACTECH, INC. k012493 08/29/2001
eris layering materials IVOCLAR NORTH AMERICA, INC. k012174 08/27/2001
human igg subclass liquid reagent kits, product code nk001.t THE BINDING SITE, LTD. k012295 08/20/2001
advanced hip assessment software GE LUNAR CORP. k011917 08/03/2001
homogeneous enzymic homocysteine reagent CATCH, INC. k011689 07/25/2001
modification to device link system, model m2376a AGILENT TECHNOLOGIES, INC. k012094 07/20/2001
cavex colorchange CAVEX HOLLAND B.V. k011419 07/16/2001
asia-med acupuncture needles, (standard, special, compact, apex) ASIA-MED GMBH AND CO KG k011808 07/10/2001
tram 2001 module GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN k011000 06/29/2001

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