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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
Date
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cellavision dm1200 automated hematology analyzer, model xu-10127 CELLAVISION AB k092868 11/20/2009
integra total wrist fusion system INTEGRA LIFESCIENCES CORPORATION k093163 12/15/2009
vinyl examination glove, powder free, non-colored QINGDAO LANG HUI IMPORT & EXPORT CO., LTD k093264 05/28/2010
non-sterile, powder-free, pink latex examination gloves with and/or without strawberry scent and with protein content OON CORP. RESOURCES k093496 02/03/2010
smartwand-dtx CLEARCOUNT MEDICAL SOLUTIONS k093557 12/18/2009
simpler toadstool abutment, model s19000-s19009 PAN GLOBAL IMPLANT k093975 06/04/2010
trans1 lateral intervertebral fusion device, t TRANS1 INCORPORATED k100210 08/26/2010
systems integration model: endoalpha OLYMPUS MEDICAL SYSTEMS CORPORATION k100345 03/22/2010
sorbact ABIGO MEDICAL AB k100591 01/24/2011
colored powder free and polymer coated examination glove (blue, black and pink) with a protein claim of less than TEKMEDIC (M) SDN BHD k100694 06/25/2010

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