510(k) K900439

SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC by L H M Ent., Inc. — Product Code FIH

K900439 is an FDA 510(k) premarket notification submitted by L H M Ent., Inc. for the device "SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC". The FDA issued a decision of Substantially Equivalent on February 15, 1990. The device falls under product code FIH (Pump, Infusion Or Syringe, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. L H M Ent., Inc. has at least 5 other 510(k) clearances on record.