510(k) K001293

MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE by Medimop Medical Projects, Ltd. — Product Code LHI

K001293 is an FDA 510(k) premarket notification submitted by Medimop Medical Projects, Ltd. for the device "MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE". The FDA issued a decision of Substantially Equivalent on May 5, 2000. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Medimop Medical Projects, Ltd. has at least 10 other 510(k) clearances on record.