510(k) K821679

LEONARD/NORTON HYPERALIMENTATION CATHET. by Norton Performance Plastics Corp. — Product Code FOZ

K821679 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "LEONARD/NORTON HYPERALIMENTATION CATHET.". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.