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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name containment system, laparoscopic power morcellation, with instrument port
De Novo Number DEN150028
Device Name PneumoLiner
unit 4 sunnybank center, upper dargle road
bray,  IE irl
Contact edward hyland
Regulation Number884.4050
Classification Product Code
Date Received06/19/2015
Decision Date 04/07/2016
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct