510(k) K935092

CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM by Contour Fabricators of Florida, Inc. — Product Code FMF

K935092 is an FDA 510(k) premarket notification submitted by Contour Fabricators of Florida, Inc. for the device "CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 10, 1994. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Contour Fabricators of Florida, Inc. has at least 10 other 510(k) clearances on record.