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U.S. Department of Health and Human Services

510(K) Premarket Notification
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natural rubber latex male condoms Karex Industries Sdn. Bhd. k141059 08/01/2014
evolution mp cs/cr porous femur/evolution adaptive cs and ps inserts Microport Orthopedics, Inc. k140735 08/29/2014
neurolumen pn-1000 Neurolumen, LLC k142025 01/21/2015
advance porous coated spiked tibial base Microport Orthopedics, Inc. k143366 01/21/2015
renasys¿ ez max negative pressure wound therapy device, renasys¿ ab abdominal dressing kit with soft port device Smith & Nephew, Inc. k143133 07/23/2015
digital automatic wrist blood pressure monitor md3200 Grandway Technology (Shenzhen) Limited k151587 08/07/2015
5.5 f worley advanced lvi lateral vein introducer Merit Medical Systems, Inc. k152116 08/27/2015
sternalock® 360 sternal closure system Biomet Microfixation k151019 11/03/2015
contour next link wireless blood glucose monitoring system, contour next blood glucose monitoring system Ascensia Diabetes Care U.S., Inc. k160430 06/24/2016
inmode plus system Inmode MD , Ltd. k153568 07/12/2016

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