FlexiMarc Marker

Accelerator, Linear, Medical

CORTEX MANUFACTURING, INC.

The following data is part of a premarket notification filed by Cortex Manufacturing, Inc. with the FDA for Fleximarc Marker.

Pre-market Notification Details

Device IDK142294
510k NumberK142294
Device Name:FlexiMarc Marker
ClassificationAccelerator, Linear, Medical
Applicant CORTEX MANUFACTURING, INC. 421 South Davies Rd. Lake Stevens,  WA  98258
ContactAndrew Jones
CorrespondentAndrew Jones
CORTEX MANUFACTURING, INC. 421 South Davies Rd. Lake Stevens,  WA  98258
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-18
Decision Date2015-03-26
Summary:summary

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