510(k) K945825

SECURE SAFETY INSERT by Syncor Intl. Corp. — Product Code FMI

K945825 is an FDA 510(k) premarket notification submitted by Syncor Intl. Corp. for the device "SECURE SAFETY INSERT". The FDA issued a decision of Substantially Equivalent on April 10, 1995. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Syncor Intl. Corp. has at least 10 other 510(k) clearances on record.