510(k) K073664

FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER by Injectimed, Inc. — Product Code MDM

K073664 is an FDA 510(k) premarket notification submitted by Injectimed, Inc. for the device "FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER". The FDA issued a decision of Substantially Equivalent on August 8, 2008. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Injectimed, Inc. has at least 2 other 510(k) clearances on record.