510(k) K050464

ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 by Ultimed, Inc. — Product Code FMI

K050464 is an FDA 510(k) premarket notification submitted by Ultimed, Inc. for the device "ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2". The FDA issued a decision of Substantially Equivalent on May 11, 2005. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Ultimed, Inc. has 7 other 510(k) clearances on record.