510(k) K990863

MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE by Ross Product Div. Abbott Laboratories — Product Code KNT

K990863 is an FDA 510(k) premarket notification submitted by Ross Product Div. Abbott Laboratories for the device "MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on April 6, 1999. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Ross Product Div. Abbott Laboratories has at least 3 other 510(k) clearances on record.