510(k) K933151

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

K933151 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 December 13, 1993. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Contour Fabricators of Florida, Inc. has at least 10 other 510(k) clearances on record.