510(k) K091637

CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 by Corpak Medsystems — Product Code KNT

K091637 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900". The FDA issued a decision of Substantially Equivalent on September 29, 2009. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Corpak Medsystems has at least 10 other 510(k) clearances on record.