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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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roccia® plif Silony Medical GmbH k181899 12/13/2018
bostonsight scleral BostonSight k183175 01/04/2019
seraquest hsv type 2 specific igg Quest International, Inc. k181514 06/13/2019
venus bliss Venus Concept USA Inc. k190743 06/25/2019
powder free nitrile examination gloves tested for use with chemotherapy drugs labeling claim (black) Comfort Rubber Gloves Industries Sdn. Bhd. k190080 06/27/2019
the powerwand safety introducer with an extended dwell catheter made of chronoflex c® with bioguard™ technology-3 fr, 4 fr, and 5 fr model Access Scientific, LLC k183066 07/25/2019
journey ii unicompartmental knee system Smith & Nephew, Inc. k191211 07/25/2019
saline wound wash, stericleanse(tm) Ascent Consumer Products, Inc. k183662 09/12/2019
ali interbody fusion system Raed M. Ali, MD., Inc. k191516 09/12/2019
hypodermic safety needle, hypodermic safety needle with syringe Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. k190183 10/04/2019

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