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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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liquichek tumor marker control-level 1; liquichek tumor marker control-level 2; liquichek tumor marker control-level 3; liquichek tumor marker control- trilevel minipak BIO-RAD LABORATORIES k163015 01/10/2017
advance capsule endoscope delivery device United States Endoscopy Group, Inc. k163495 03/10/2017
trovita health science safe-t feed ready-to-feed pouch with enfit connector TrovRx, Inc. dba Trovita Health Science k163586 03/17/2017
locator rtx ZEST ANCHORS, INC. k150295 07/24/2015
cardinal health external fixation system CARDINAL HEALTH k150579 04/29/2015
emit ii plus buprenorphine assay, emit ii plus specialty drug calibrator/control level 1, level 2 level 3, level 4, emit ii plus specialty drug control negative, emit ii plus specialty drug control positive SIEMENS HEALTHCARE DIAGNOSTICS, INC. k150606 10/23/2015
leforte system ii Jeil Medical Corporation k150965 09/17/2015
azur cx detachable 35 coils Micro Vention, Inc. k151358 09/25/2015
gemmed pedicle screw spinal system SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. k151592 09/24/2015
cardiac trigger monitor, cardiac & regulatory synchronization monitor IVY BIOMEDICAL SYSTEMS INC. k151781 05/27/2016

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