FDA 510(k), K191340, CORTRAK 2 Equilateral Enteral Access System
FDA 510(k), K191340, CORTRAK 2 Equilateral Enteral Access System
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: KXA
Date Received: 05/20/2019
Decision Date: 06/04/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Total pages: 12,302
Fully redacted pages: 11,003
Content pages: 1,299
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