510(k) K042917

STAT MEDICAL PEN NEEDLE by Emergogroup, Inc. — Product Code FMI

K042917 is an FDA 510(k) premarket notification submitted by Emergogroup, Inc. for the device "STAT MEDICAL PEN NEEDLE". The FDA issued a decision of Substantially Equivalent on April 22, 2005. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Emergogroup, Inc. has at least 1 other 510(k) clearance on record.