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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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synthes (usa) 3.5mm lcp periarticular proximal humerus plates SYNTHES (USA) k082625 12/17/2008
spectra-glass lor (loss of resistance syringe, 5cc metal l/s or l/l tip, spectra-glass lor (loss of resistance) syringe SPECTRA MEDICAL DEVICES, INC. k082674 11/28/2008
nevoni classic, model 6600-po NSR COMERCIO E REPRESENTACOES LTDA k082878 12/30/2008
terumo hybria closed system safety i.v. catheter TERUMO MEDICAL CORP. k082997 04/15/2009
echelon high resolution foot coil (mr-hrf-150), echelon long bone coil (mr-lbc-150) HITACHI MEDICAL SYSTEMS AMERICA, INC. k083086 12/05/2008
versafit cup double mobility system MEDACTA INTERNATIONAL, SA k083116 04/07/2009
acrylic herbst splint appliance SPECIALTY APPLIANCE WORKS, INC. k083209 01/27/2009
powder free nitrile examination gloves, sterile with chemotherapy claim WRP ASIA PACIFIC SDN. BHD. k083305 06/18/2009
semi-fully automatic electronic blood pressure monitor, models: kd-322,kd-622,kd-575,kd-525e,kd-593,kd-595,kd-596,kd-598 ANDON HEALTH CO.,LTD k083395 02/27/2009
dimension vista beta 2 microglobulin, dimension vista protein 1 calibrator, dimension vista protein 1 control m SIEMENS HEALTHCARE DIAGNOSTICS k083463 03/13/2009

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