510(k) K102898

BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE by Panpac Medical Corporation — Product Code LKF

K102898 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE". The FDA issued a decision of Substantially Equivalent on December 15, 2011. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Panpac Medical Corporation has at least 10 other 510(k) clearances on record.