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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 10 Results
ProductCode: JXG Applicant: INTEGRA LIFESCIENCES CORPORATION Decision Date To: 06/29/2022
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monitorr icp external drainage and monitoring system, limitorr volume limiting external csf drainage system Integra Lifesciences Corporation K191684 10/11/2019
horizontal-vertical lumbar valve systems, spetzler lumbar peritoneal shunt systems INTEGRA LIFESCIENCES CORPORATION K161992 09/22/2016
bundled neurological shunts and accessories product families labeling modification to support mr conditional labeling INTEGRA LIFESCIENCES CORPORATION K153041 03/14/2016
integra dp valve systems (including burr hole reservoirs and stainless steel connectors), gravity compensating accessory INTEGRA LIFESCIENCES CORPORATION K152897 03/04/2016
integra flow regulating valve systems osv ii models and integra flow regulating valve low flow models INTEGRA LIFESCIENCES CORPORATION K140722 01/06/2015
horizontal-vertical lumbar valve and spetzler lumbar peritoneal shunt systems INTEGRA LIFESCIENCES CORPORATION K101381 07/07/2011
osv ii low flow low pro valve INTEGRA LIFESCIENCES CORPORATION K093968 01/22/2010
limitorr volume limiting external csf drainage and monitoring system, models ins9020, ins9030 INTEGRA LIFESCIENCES CORPORATION K072929 12/07/2007
monitorr icp external drainage and monitoring systems INTEGRA LIFESCIENCES CORPORATION K062599 09/27/2006
accudrain external csf drainage system INTEGRA LIFESCIENCES CORPORATION K042825 12/21/2004
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