510(k) K100812

ULTICARE DISPOSABLE PEN NEEDLES by Ultimed, Inc. — Product Code FMI

K100812 is an FDA 510(k) premarket notification submitted by Ultimed, Inc. for the device "ULTICARE DISPOSABLE PEN NEEDLES". The FDA issued a decision of Substantially Equivalent on Jun 3, 2010. 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.