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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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mpact extension MEDACTA INTERNATIONAL k132879 01/22/2014
immulite 2000; hcg calibration verification material, insulin calibration verification material, pyrilinks-d calibration Siemens Healthcare Diagnostics Inc. k133128 10/22/2013
e-fit ef-1280 ems machine FIT-PRO KFT LTD. k133225 10/24/2014
steritec biological test pack with instant readout integrator STERITEC PRODUCTS MFG., CO., INC. k133549 08/27/2014
sonotip pro and pro flex ebus-tbna needle system MEDI-GLOBE CORPORATION k133763 05/15/2014
4.5mm healix advance br anchor, with 2 or 3 strands of #2 permacord suture, 5.5mm healix advance br anchor, with 2 or 3 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY k133794 02/04/2014
health expert elctronic stimulator SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED k133929 11/12/2014
senzzzzz away CENTRIX, INC. k120176 07/25/2012
neria multi subcutaneous infusion set UNOMEDICAL DEVICES S.A DE C.V k120395 05/30/2012
innesis peek cage BK MEDITECH CO., LTD. k120464 01/18/2013

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