510(k) K831970

VIVONEX TUNGSTEN TIP TUBE-MONOFILA- by Norwich Eaton Pharmaceuticals, Inc. — Product Code KNT

K831970 is an FDA 510(k) premarket notification submitted by Norwich Eaton Pharmaceuticals, Inc. for the device "VIVONEX TUNGSTEN TIP TUBE-MONOFILA-". The FDA issued a decision of Substantially Equivalent on July 18, 1983. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Norwich Eaton Pharmaceuticals, Inc. has at least 9 other 510(k) clearances on record.