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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 general laparoscopic power morcellation containment system
De Novo Number DEN170075
Device Name ContainOR
Advanced Surgical Concepts Ltd.
unit 4 sunnybank center, upper dargle road
bray,  IE a98 e339
Contact edward hyland
Regulation Number878.4825
Classification Product Code
Date Received09/29/2017
Decision Date 12/19/2017
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct