510(k) K980062

MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE by Davis & Geck, Inc. — Product Code FMI

K980062 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE". The FDA issued a decision of Substantially Equivalent on March 20, 1998. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.