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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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desara sl CALDERA MEDICAL, INC. k121928 02/19/2013
navigator delivery system (navigator ds) CARTICEPT MEDICAL, INC. k122215 10/26/2012
amigo remote catheter system & accessories CATHETER ROBOTICS INC k122488 11/20/2012
hemotherm model 400ce cooler/heater system CINCINNATI SUB-ZERO PRODUCTS, INC. k122813 12/18/2012
ethicon securestrap open absorbable strap fixation device ETHICON, INC. k123114 02/05/2013
twinfix ti 3.5mm suture anchor with two ultrabraid suture #2 with needles, sl SMITH & NEPHEW, INC. k123425 02/20/2013
warming jelly personal lubricant WISCONSIN PHARMACAL CO., LLC k123770 04/09/2013
surecall labor monitor REPRODUCTIVE RESEARCH TECHNOLOGIES, LP k130002 06/28/2013
xtag cyp2d6 kit v3 (including tdas cyp2d6 software) LUMINEX MOLECULAR DIAGNOSTICS, INC. k130189 05/21/2013
ifusion OPTOVUE, INC. k130656 07/03/2013

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