510(k) K903340

STERILE URETHRAL CATHETER PROCEDURE KITS by Superior Healthcare Group, Inc. — Product Code FCM

K903340 is an FDA 510(k) premarket notification submitted by Superior Healthcare Group, Inc. for the device "STERILE URETHRAL CATHETER PROCEDURE KITS". The FDA issued a decision of Substantially Equivalent (with conditions) on October 4, 1990. 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. Superior Healthcare Group, Inc. has at least 10 other 510(k) clearances on record.