FLEX FINDER GUIDEWIRE

Endoscopic Guidewire, Gastroenterology-urology

Flex Medics Corporation

The following data is part of a premarket notification filed by Flex Medics Corporation with the FDA for Flex Finder Guidewire.

Pre-market Notification Details

Device IDK923755
510k NumberK923755
Device Name:FLEX FINDER GUIDEWIRE
ClassificationEndoscopic Guidewire, Gastroenterology-urology
Applicant Flex Medics Corporation 12400 Whitewater Drive, Suite 2040 Minnetonka,  MN  55343
ContactDaniel Corcoran
CorrespondentDebra K. Fritz
Flex Medics Corporation 12400 Whitewater Drive, Suite 2040 Minnetonka,  MN  55343
Product CodeOCY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-24
Decision Date1993-09-03

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