510(k) K961442

UNIVERSAL DRAINAGE TRAY by Customed, Inc. — Product Code FCM

K961442 is an FDA 510(k) premarket notification submitted by Customed, Inc. for the device "UNIVERSAL DRAINAGE TRAY". The FDA issued a decision of Substantially Equivalent on May 9, 1996. The device falls under product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)), a Class II device regulated under 21 CFR 876.5130. Customed, Inc. has at least 10 other 510(k) clearances on record.