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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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Decision
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elecsys dhea-s calcheck 5 Roche Diagnostics k103402 01/07/2011
dx-d 100 AGFA HEALTHCARE N.V. k103597 01/03/2011
the infrared forehead thermometer, model fs-300&301 HUBDIC CO., LTD k101912 11/10/2010
baby quasar SILVER BAY, LLC k091467 09/17/2010
arrowgard evolution antimicrobial peripherally inserted central catheter (picc) model: s-44041-002, s-45041-002, s-45504 ARROW INTL., INC. k100635 08/27/2010
guide wire for edi catheter, 8fr,125cm,5 each,guide wire for edi catheter, 8fr,125cm,5 each,guide wire for edi catheter, MAQUET CRITICAL CARE AB k101199 08/27/2010
mdpo frame system MDPO, LLC k093753 08/26/2010
non-chlorinated, polymer coated powder free natural rubber latex examination gloves and protein labeling claim of LATEXX MANUFACTURING SDN.BHD. k101645 08/26/2010
ascend blue ac mesh; ascend blue pc mesh CALDERA MEDICAL, INC. k101462 08/16/2010
lanx spinal fixation system LANX, INC. k100935 08/06/2010

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