510(k) K820710

NEONATAL INTRODUCER KIT by Norton Performance Plastics Corp. — Product Code DYB

K820710 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "NEONATAL INTRODUCER KIT". The FDA issued a decision of Substantially Equivalent on April 1, 1982. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.