510(k) K890096

BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG by Medical Inventors Corp., Inc. — Product Code FCN

K890096 is an FDA 510(k) premarket notification submitted by Medical Inventors Corp., Inc. for the device "BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code FCN (Urinary Drainage Collection Kit, For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Medical Inventors Corp., Inc. has at least 1 other 510(k) clearance on record.