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FDA 510(k), K191340, CORTRAK* 2 Equilateral Enteral Access System
FDA 510(k), K191340, CORTRAK* 2 Equilateral Enteral Access System
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$149.00 USD
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510(K) Number: K191340
Device Name: CORTRAK* 2 Equilateral Enteral Access System
Manufacturer: Monica King
Device Classification Name: Tubes, Gastrointestinal (And Accessories)
Regulation Number: KNT
Classification Product Code: 05/20/2019
Date Received: 06/04/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: CORTRAK* 2 Equilateral Enteral Access System
Manufacturer: Monica King
Device Classification Name: Tubes, Gastrointestinal (And Accessories)
Regulation Number: KNT
Classification Product Code: 05/20/2019
Date Received: 06/04/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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