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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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glycosylated hemoglobin assay; clinical chemistry BECKMAN COULTER, INC k120199 10/12/2012
transcend SYNERON MEDICAL LTD. k120510 07/19/2013
leksell gamma knife perfexion ELEKTA INSTRUMENT AB k120811 05/24/2012
diamond calibrator low, diamond calibrator high DIAMOND DIAGNOSTICS, INC k121027 12/20/2012
cook celect and gunther tulip vena cava filter sets WILLIAM COOK EUROPE APS k121057 05/04/2012
das medical equipment drapes DAS MEDICAL, LLC k121436 06/06/2013
colored powder free latex examination glove (white and blue) TEKMEDIC (M) SDN BHD k121594 10/25/2012
laminar flow phaco tips and irrigation sleeve (21g, reusable) ABBOTT MEDICAL OPTICS INC k121721 10/15/2012
hepafat scan RESONANCE HEALTH ANALYSIS SERVICES PTY LTD k122035 12/13/2013
no-profile screws no-profile washer no-profile screws washerloc washers BIOMET SPORTS MEDICINE k122437 10/18/2013

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