510(k) K821172

EXTERNAL FEMALE URINARY INCONTINENCE by The Healthcare Group Laboratories, Inc. — Product Code KNX

K821172 is an FDA 510(k) premarket notification submitted by The Healthcare Group Laboratories, Inc. for the device "EXTERNAL FEMALE URINARY INCONTINENCE". The FDA issued a decision of Substantially Equivalent on May 10, 1982. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. The Healthcare Group Laboratories, Inc. has at least 10 other 510(k) clearances on record.