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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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numed z-med ptv catherers NUMED, INC. k003643 12/27/2000
eyetect tremor monitor unit (tmu) EYETECT, L.L.C. k003644 02/01/2001
suturegroove weight sizing set IOP, INC. k003646 02/22/2001
instant-view barbiturate urine cassette test ALFA SCIENTIFIC DESIGNS, INC. k003647 05/29/2001
freedland tension system ETZEM TECHNOLOGIES, INC. k003648 02/23/2001
triton hip system HAYES MEDICAL, INC. k003649 02/23/2001
permlastic 3 SYBRON DENTAL SPECIALTIES, INC. k003650 02/15/2001
aurora AURORA IMAGING TECHNOLOGY, INC. k003651 02/21/2001
sterile powder free polymer coated latex examination gloves, with protein labeling claim (50 microgram or less) WRP ASIA PACIFIC SDN. BHD. k003653 01/26/2001
phs-63 pediatric head and spine array coil MRI DEVICES CORP. k003655 02/02/2001

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