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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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Decision
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panbio indx igm dip-s-ticks leptospirosis test for the detection of igm antibodies to leptospira biflexa PANBIO, INC. k002024 11/22/2000
rigid gas permeable contact lens POLYMER TECHNOLOGY k002025 10/31/2000
capiox arterial filter TERUMO MEDICAL CORP. k002026 09/06/2000
bravo ph monitoring system ENDONETICS, INC. k002028 09/29/2000
zoll m series nibp option, model mseries nibp option ZOLL MEDICAL CORP. k002029 09/21/2000
omni-trak 3150/3155a series monitor with anesthetic agent, model 3155a series INVIVO RESEARCH, INC. k002030 09/26/2000
phacofragmentation system megatron ASCLEPION-MEDITEC AG k002031 12/27/2000
c02 laser multipulse ASCLEPION-MEDITEC AG k002032 09/11/2000
bd insyte autoguard -p and bd insyte autoguard -p winged iv catheters BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. k002033 07/26/2000
osi medical dolphin stand-alone pulse oximeter, model 2100 and digital dolphin optical sensor, clip-on finger probe, mod OSI MEDICAL, INC. k002036 04/17/2001

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