DuraFuse Clip And Applier System

Clip, Implantable

NeuraMedica Inc

The following data is part of a premarket notification filed by Neuramedica Inc with the FDA for Durafuse Clip And Applier System.

Pre-market Notification Details

Device IDK213813
510k NumberK213813
Device Name:DuraFuse Clip And Applier System
ClassificationClip, Implantable
Applicant NeuraMedica Inc 402 Beavercreek Road, Suite 110 Oregon City,  OR  97045
ContactRachel Dreilinger
CorrespondentRachel Dreilinger
NeuraMedica Inc 402 Beavercreek Road, Suite 110 Oregon City,  OR  97045
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-07
Decision Date2022-07-22

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