510(k) K962073

URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY by Continental Medical Laboratories, Inc. — Product Code FCM

K962073 is an FDA 510(k) premarket notification submitted by Continental Medical Laboratories, Inc. for the device "URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY". The FDA issued a decision of Substantially Equivalent on June 21, 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. Continental Medical Laboratories, Inc. has at least 7 other 510(k) clearances on record.