510(k) K831553

LEG DRAINAGE BAG STRAP BK6011 by Fred Sammons, Inc. — Product Code KNX

K831553 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "LEG DRAINAGE BAG STRAP BK6011". The FDA issued a decision of Substantially Equivalent on June 16, 1983. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.