More-Cell-System

Containment System, Laparoscopic Power Morcellation, With Instrument Port

Agency For Medical Innovations GmbH

The following data is part of a premarket notification filed by Agency For Medical Innovations Gmbh with the FDA for More-cell-system.

Pre-market Notification Details

Device IDK212659
510k NumberK212659
Device Name:More-Cell-System
ClassificationContainment System, Laparoscopic Power Morcellation, With Instrument Port
Applicant Agency For Medical Innovations GmbH Im Letten 1 Feldkirch,  AT 6800
ContactMartin Hohlrieder
CorrespondentAllison Komiyama
AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego,  CA  92110
Product CodePMU  
CFR Regulation Number884.4050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-23
Decision Date2021-11-10

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