510(k) K991273

SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE by Swemed Lab International AB — Product Code MQE

K991273 is an FDA 510(k) premarket notification submitted by Swemed Lab International AB for the device "SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE". The FDA issued a decision of Substantially Equivalent on August 18, 1999. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Swemed Lab International AB has at least 3 other 510(k) clearances on record.