Avanos* CORTRAK* 2 Enteral Access System (EAS)

Tubes, Gastrointestinal (and Accessories)

Avanos Medical Inc

The following data is part of a premarket notification filed by Avanos Medical Inc with the FDA for Avanos* Cortrak* 2 Enteral Access System (eas).

Pre-market Notification Details

Device IDK220588
510k NumberK220588
Device Name:Avanos* CORTRAK* 2 Enteral Access System (EAS)
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant Avanos Medical Inc 5405 Windward Parkway Alpharetta,  GA  30004
ContactNikin Desai
CorrespondentAngela Cushman
Avanos Medical, Inc. 5405 Windward Parkway Alpharetta,  GA  30004
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-01
Decision Date2022-04-22

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