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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
Date
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asserachrom hpia test kit DIAGNOSTICA STAGO, INC. k003767 02/12/2001
astoflo NATS CORP. k020060 03/05/2002
athos laser QUANTEL MEDICAL k020072 04/09/2002
atlantis sr plus coronary imaging catheter, model 35975 BOSTON SCIENTIFIC, TARGET k010707 03/29/2001
au6 (technos/technos mp) ultrasound imaging system (addition of 3d imaging mode and musculoskeletal indication) BIOSOUND ESAOTE, INC. k014168 04/25/2002
auto suture surgical staples UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k013860 12/19/2001
auto-drive lag screw system OSTEOMED CORP. k010964 07/05/2001
autodimer assay model # 1431 XTRANA, INC. k012755 03/15/2002
autovac orthopedic autotransfusion system BOEHRINGER LABORATORIES k014187 02/06/2002
avera model dei system (diffractive energy imaging system) ADVANCED DIAGNOSTICS, INC. k013886 05/10/2002

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