510(k) K960982

MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA by Sherwood Medical Co. — Product Code FMI

K960982 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA". The FDA issued a decision of Substantially Equivalent on December 23, 1996. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.