510(k) K896581

PEDIATRIC DRAIN BAG by Laytech Medical Co. — Product Code FFH

K896581 is an FDA 510(k) premarket notification submitted by Laytech Medical Co. for the device "PEDIATRIC DRAIN BAG". The FDA issued a decision of Substantially Equivalent on January 31, 1990. The device falls under product code FFH (Collector, Urine, Pediatric, For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Laytech Medical Co. has at least 1 other 510(k) clearance on record.