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U.S. Department of Health and Human Services

510(K) Premarket Notification

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hemosil pt-fibrinogen hs plus INSTRUMENTATION LABORATORY CO. k060931 05/02/2006
novabone putty - bioactive synthetic graft NovaBone Products, LLC k060728 05/01/2006
navitrack system-os knee universal, model pro-05002 ORTHOSOFT, INC. k060336 04/28/2006
kendall monoject pre-fill advanced 0.9%sodium chloride flush syringes for sterile delivery TYCO HEALTHCARE/KENDALL k060339 04/28/2006
nova statstrip glucose hospital meter, statstrip control solutions NOVA BIOMEDICAL CORP. k060345 04/28/2006
modification to: tamper evident ultrasafe passive delivery system, ultrasafe passive delivery system (x-series) SAFETY SYRINGES, INC. k060743 04/28/2006
immulite 2500 vitamin b12 model l5kvb2-200 test,l5kvb6-600 test, immulite 2500 folic acid model l5kfo2-200 test,l5kfo6-6 DIAGNOSTIC PRODUCTS CORPORATION k060929 04/28/2006
synchron systems creatinine (crea) reagent BECKMAN COULTER, INC. k060935 04/28/2006
amplatzer noodlewire guidewire AGA MEDICAL CORP. k053187 04/27/2006
velscope LED MEDICAL DIAGNOSTICS INC. k060920 04/27/2006

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