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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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Applicant
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510(K)
Number
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Decision
Date
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14.5 fr chronic hemodialysis catheter with insertion stylets accessory KENDALL k051584 10/06/2005
21.3-inch(54 cm) monochrome lcd monitor mdl2115a (me353i), (dv3mm-hb), (me353im) TOTOKU ELECTRIC CO., LTD k052199 09/22/2005
21.3inch monochrome lcd monitor NEC-MITSUBISHI ELECTRIC VISUAL SYSTEMS CORP. k052942 12/27/2005
3m littmann electronic stethoscope, model 4100 3M COMPANY k051790 07/25/2005
4.5.* 6.0mm dental implant and 6.0*6.0 mm dental implant BICON, INC. k050712 04/22/2005
55 sv, multifocal and toric (ocufilcon c) soft (hydrophilic) contact lens for daily wear UNITED CONTACT LENS, INC. k051184 07/01/2005
5th metatarsal fracture screw WRIGHT MEDICAL TECHNOLOGY, INC. k053136 01/05/2006
absoanchor microimplant DENTOS INC. k060126 05/16/2006
absolute .035 self-expanding biliary stent system GUIDANT CORP. k033393 11/10/2003
abx micros crp 200, option im HORIBA ABX k053308 12/29/2005

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