510(k) K013491

HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 by A & A Medical, Inc. — Product Code LKF

K013491 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948". The FDA issued a decision of Substantially Equivalent on November 19, 2001. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.