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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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glucommander plus COLLABORATIVEMED, LLC k061110 06/07/2006
capsuls, models 2003-pur8c, 2004-pvc8c ISOVAC PRODUCTS LLC k052798 06/06/2006
dimension urine ecstasy screen flex reagent cartridge, model df 109 DADE BEHRING, INC. k053337 05/19/2006
port-a-cath, port-a-cath ii, proport and p.a.s. port implantable venous access systems with dual layer catheter SMITHS MEDICAL MD, INC. k060036 05/17/2006
rc loop /dual orthocord suture,rc loop w/ethibond suture,rc loop w/panacryl suture DEPUY MITEK, A JOHNSON & JOHNSON COMPANY k060553 05/04/2006
drilltech, ism, implantunit, zimmer surgical motor system W & H DENTALWERK BUERMOOS GMBH k060287 05/03/2006
modified pva-plus foam embolization particles and maxistat and microstat pva foam embolization particles PROTEIN POLYMER TECHNOLOGIES, INC. k053548 01/30/2006
c-flex system single use disposable injector, model r-inj-02 RAYNER SURGICAL INC k052651 01/19/2006
mylab15/20 3d/4d ultrasound imaging system PIE MEDICAL k053154 12/16/2005
surflo winged infusion set with needle protection (surshield), model sv-s23bl35vs TERUMO EUROPE N.V. k052887 12/08/2005

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