510(k) K890377

FIXED-SIZE UTERINE DILATOR by Kinetic Medical Products — Product Code HDQ

K890377 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "FIXED-SIZE UTERINE DILATOR". The FDA issued a decision of Substantially Equivalent on February 13, 1989. The device falls under product code HDQ (Dilator, Cervical, Fixed Size), a Class I device regulated under 21 CFR 884.4530. Kinetic Medical Products has at least 10 other 510(k) clearances on record.