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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)
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Decision
Date
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tamponade uterine balloon catheter set COOK OB/GYN k013597 04/17/2002
reuse claim for the bard electrophysiology surelink, templink, and templink m extension cables C.R. BARD, INC. k013598 01/11/2002
numed mullins pta catheter NUMED, INC. k013601 01/03/2002
hnc-63-int neurovascular array coil MRI DEVICES CORP. k013602 11/20/2001
modification to:micro touch (r) powder free latex surgical gloves , model style 65 ANSELL HEALTHCARE PRODUCTS, INC. k013603 11/13/2001
modification to: ultralon (r) powder free latex surgical gloves ANSELL HEALTHCARE PRODUCTS, INC. k013604 11/13/2001
acs 180 homocysteine assay BAYER DIAGNOSTICS CORP. k013606 12/21/2001
digital radiography system, model dfp-8000d TOSHIBA AMERICA MEDICAL SYSTEMS, INC. k013608 11/15/2001
nexus 2 clear SYBRON DENTAL SPECIALTIES, INC. k013609 01/16/2002
perifix safety epidural needles B. BRAUN MEDICAL, INC. k013610 01/25/2002

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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