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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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510(K)
Number
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Decision
Date
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power 5000 general purpose coil USA INSTRUMENTS, INC. k002483 10/25/2000
biosensors central venous catheter kits SUNSCOPE INTL., INC. k002786 11/17/2000
comfit chemo plus powder free blue nitrile examination gloves, non sterile (tested for use with chemotherapy drug) label WRP ASIA PACIFIC SDN. BHD. k002064 11/28/2000
caleo DRAGER MEDIZINTECHNIK GMBH k003067 12/13/2000
medlogics ml 4000, model 4000 MED-LOGICS, INC. k002515 02/22/2001
sigma dianostics auto d-dimer control level 2, model a5217 SIGMA DIAGNOSTICS, INC. k003329 03/01/2001
7230 ultrasound imaging system with tei BIOSOUND ESAOTE, INC. k010405 03/13/2001
endius bipolar sheath ENDIUS, INC. k003897 03/22/2001
avita piccolo/exato infared ear thermometer (ts2 & ts4 series) AVITA CORPORATION k010462 04/11/2001
vectorvision cranial, vectorvision spinal, vectorvision ent BRAINLAB AG k003589 05/21/2001

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