NEO ERCP GUIDEWIRE

Endoscopic Guidewire, Gastroenterology-urology

NEOMETRICS, INC.

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

Pre-market Notification Details

Device IDK123439
510k NumberK123439
Device Name:NEO ERCP GUIDEWIRE
ClassificationEndoscopic Guidewire, Gastroenterology-urology
Applicant NEOMETRICS, INC. 2605 FERNBROOK LANE N. SUITE J Plymouth,  MN  55447
ContactGene Champeau
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeOCY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-11-08
Decision Date2013-01-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.