Predicate III Guidewire

Endoscopic Guidewire, Gastroenterology-urology

Lake Region Medical

The following data is part of a premarket notification filed by Lake Region Medical with the FDA for Predicate Iii Guidewire.

Pre-market Notification Details

Device IDK142397
510k NumberK142397
Device Name:Predicate III Guidewire
ClassificationEndoscopic Guidewire, Gastroenterology-urology
Applicant Lake Region Medical 340 Lake Hazeltine Dr. Chaska,  MN  55318
ContactMathew Pexa
CorrespondentMathew Pexa
Lake Region Medical 340 Lake Hazeltine Dr. Chaska,  MN  55318
Product CodeOCY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-27
Decision Date2014-09-19
Summary:summary

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