510(k) K945131

IMAGYN INTRAUTERINE INSEMINATION DEVICE by Imagyn Medical, Inc. — Product Code HDR

K945131 is an FDA 510(k) premarket notification submitted by Imagyn Medical, Inc. for the device "IMAGYN INTRAUTERINE INSEMINATION DEVICE". The FDA issued a decision of Substantially Equivalent on May 15, 1995. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. Imagyn Medical, Inc. has at least 10 other 510(k) clearances on record.