510(k) K891109

PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE by Concept, Inc. — Product Code KNT

K891109 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on May 8, 1989. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Concept, Inc. has at least 10 other 510(k) clearances on record.