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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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orbiter ii cci/spect orbiter ii cci/spect SIEMENS MEDICAL SOLUTIONS USA, INC. k010137 02/13/2001
portable instensive care unit MEDICAL RESEARCH LABORATORIES, INC. k010207 06/14/2001
precise nitinol stent transhepatic billary system CORDIS CORP. k010445 03/16/2001
powdered synthetic vinyl patient examination gloves SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. k010628 04/23/2001
oxylog 1000, model 2m86840 DRAGER MEDIZINTECHNIK GMBH k010793 12/20/2001
lift vb spinal system MEDTRONIC SOFAMOR DANEK, INC. k010930 10/24/2001
bsm bone substitute material DEPUY ORTHOPAEDICS, INC. k011048 11/13/2001
reveal plus insertable loop recorder system model 9526 implantable recorder and model 6191 patient activator MEDTRONIC VASCULAR k011098 05/04/2001
sparc sling system AMERICAN MEDICAL SYSTEMS, INC. k011251 08/01/2001
biocurve soft (hioxifilcom a) spherical and toric soft contact lens for daily wear (clear and blue visibility-handling t AMERICAN CONTACT LENS, INC. k011316 06/13/2001

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