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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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canvas n-vas-d 2.0 VASSOL, INC. k014011 02/05/2002
doc band CRANIAL TECHNOLOGIES, INC. k014012 01/28/2002
h & w hospital ethylene oxide sterilizer control system H & W TECHNOLOGY, LLC k014013 06/25/2003
lifesign cocaine, marijuana (thc), lifesign doa2 (thc/coc), status stik thc/coc, accusign stik thc/coc, accustik thc/coc PRINCETON BIOMEDITECH CORP. k014067 06/10/2002
pmx disposable bag mask resuscitator ALLIED HEALTHCARE PRODUCTS, INC. k014071 10/01/2002
fixion unipolar modular hemi-hip system (fixion uh) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. k014072 03/08/2002
hypodermic needle-pro insulin syrine & needle with needle protection device PORTEX, INC. k014073 02/13/2002
hoffrichter vector, vector plus, vector bi-vevel, vector bi-level plus, scalar, scalar plus; cpap with humidifier option HOFFRICHTER GMBH k014074 07/23/2003
bmc coaxial injectable catheter, model cic 38/145 and cic 35/145 BAYLIS MEDICAL CO., INC. k014075 03/07/2002
powder-free latex exam gloves with protein labeling (<50ug/g) SUPERGRADE HEALTHCARE PRODUCTS SDN. BHD. k014134 01/22/2002

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