510(k) K992308

OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138 by Lifetek Medical, Inc. — Product Code MQE

K992308 is an FDA 510(k) premarket notification submitted by Lifetek Medical, Inc. for the device "OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138". The FDA issued a decision of Substantially Equivalent on September 13, 1999. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Lifetek Medical, Inc. has at least 1 other 510(k) clearance on record.