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U.S. Department of Health and Human Services

510(K) Premarket Notification
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glocyte automated cell counter system Advanced Instruments, Inc. k152776 05/27/2016
emg powder free nitrile examination glove (blue) with peppermint scented ECO MEDI GLOVE SDN. BHD. k152937 06/23/2016
6200 ultrasound system and 6250 ultrasound system Esaote S.p.A. k153277 05/04/2016
eyeyon (hioxirilcon d) soft (hydrophillc) contactlensesfor daily wear, hyper-cl (hioxirilcon d)therapeuticsoft (hydrophillc) contact lensesfor daily wear EYEYON MEDICAL k153305 04/08/2016
lifestream management system, lifestream management suite, lifestream patient manager, lifestream manager, lifestream web manager, lifestream HONEYWELL HOMMED, LLC k153719 06/03/2016
sonoma fibula repair system Sonoma Orthopedics Products, Inc k160069 03/10/2016
vivo 60 BREAS MEDICAL AB k160481 11/09/2016
powder free vinyl patient examination glove, colored (yellow) KAIXING PLASTIC PRODUCTS CO., LITD. k160675 08/02/2016
gexfix external fixation Gexfix International Corp. k160972 12/28/2016
arrow pressure injectable midline catheter with chlorag+ard antimicrobial and antithrombogenic technology ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) k161313 08/24/2016

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