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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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powder free vinyl patient examination gloves, clear (non-colored) SHANDONG JIANHONG NEW MATERIAL COMPANY k111752 07/27/2011
spi vario angled abutment THOMMEN MEDICAL, AG k111984 11/10/2011
lccs insulated spinal needle (rf cannula) LCCS PRODUCTS LIMITED k112231 08/19/2011
architect active b-12 (holotranscobalamin) AXIS-SHIELD DIAGNOSTICS, LTD. k112443 12/19/2011
ace cholesterol reagent, ace hdl-c reagent, ace ldl-c reagent, ace triglycerides reagent ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. k112538 03/29/2012
frontier sadl interbody fusion device FRONTIER MEDICAL DEVICES, INC. k112700 11/01/2012
puresleep SLEEP SCIENCE PARTNERS, INC. k113022 06/11/2012
cardio 7 BIONET CO., LTD. k113306 07/16/2012
freedom inguinal hernia implant Insightra Medical k113552 08/23/2012
megabeam endocular probe and aspirating endocular probe BIOLITEC MEDICAL DEVICES, INC k113792 01/19/2012

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