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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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spotchem ii chemistry basic 1 and chemistry basic 2 tests ARKRAY, INC. k053401 03/24/2006
lucas JOLIFE AB k053403 02/01/2006
lifestent flexstart biliary stent system EDWARDS LIFESCIENCES, LLC. k053404 12/21/2005
bacstop ELCAM MEDICAL A.C.A.L. k053405 05/11/2006
barrierplus gold powder-free synthetic polyisoprene surgical gloves BARRIERMED GLOVE CO. k053406 07/05/2006
oxygen analyzer, models aii 20000a, aii 2000hc, aii 2000m ANALYTICAL INDUSTRIES, INC. k053407 04/05/2006
nexa bone plate and screw system NEXA ORTHOPEDICS, INC. k053408 12/22/2005
3m liquid bandage 3M COMPANY k053409 06/19/2006
gientriport with universal single lumen adaptor KENDALL k053410 01/06/2006
dri hemoglobin a1c assay and calibrators MICROGENICS CORP. k053411 02/03/2006

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