NovaGold High Performance Guidewire

Endoscopic Guidewire, Gastroenterology-urology

NEOMETRICS, INC.

The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Novagold High Performance Guidewire.

Pre-market Notification Details

Device IDK150225
510k NumberK150225
Device Name:NovaGold High Performance Guidewire
ClassificationEndoscopic Guidewire, Gastroenterology-urology
Applicant NEOMETRICS, INC. 2605 FERNBROOK LANE N. SUITE J Plymouth,  MN  55447
ContactDave Liebl
CorrespondentDave Liebl
NEOMETRICS, INC. 2605 FERNBROOK LANE N. SUITE J Plymouth,  MN  55447
Product CodeOCY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-02
Decision Date2015-03-16
Summary:summary

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