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U.S. Department of Health and Human Services

510(K) Premarket Notification
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vanguard iep peripheral balloon angioplasty system with integrated embolic protection Contego Medical, LLC k181529 12/06/2018
bausch + lomb boston simplusmulti-action solution, bausch + lomb boston one step liquid enzymatic cleaner Bausch & Lomb Incorporated k181627 08/10/2018
osstem abutment system Osstem Implant Co., Ltd. k182091 07/12/2019
medline level 4 surgical gown (sirus), medline level 4 surgical gown (eclipse), medline level 4 surgical gown (aurora) Medline Industries, Inc. k182172 04/24/2019
largan 55 uv color (ocufilcon d) daily wear soft (hydrophilic) contact lens Largan Medical Co., Ltd. k182523 11/01/2018
adult intraosseous infusion device Einstein Works, L.L.C k182770 04/09/2019
boston es (enflufocon a) rigid gas permeable contact lens; boston eo (enflufocon b) rigid gas permeable contact lens; boston xo (hexafocon a) rigid gas permeable contact lens; boston xo2 (hexafocon b) rigid gas permeable contact lens Bausch & Lomb, Incorporated k183167 02/12/2019
verify v24 self-contained biological indicator, verify v24 biological indicator challenge pack STERIS Corporations k183300 01/03/2019
aristotle 18 guidewire, 200cm, soft profile ; aristotle 18 guidewire, 200cm, standard profile ; aristotle 18 guidewire, 200cm, support profile Scientia Vascular LLC k183608 03/22/2019
aidite pmma Aidite (Qinhuangdao) Technology Co., Ltd. k190217 12/17/2020

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