510(k) K843128

FEMALE URINARY INCONTINENCE SYS by Chesebrough-Pond'S U.S.A. Co. — Product Code KNX

K843128 is an FDA 510(k) premarket notification submitted by Chesebrough-Pond'S U.S.A. Co. for the device "FEMALE URINARY INCONTINENCE SYS". The FDA issued a decision of Substantially Equivalent on January 2, 1985. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Chesebrough-Pond'S U.S.A. Co. has at least 10 other 510(k) clearances on record.