510(k) K950390

URETHRAL CATHETERIZATION TRAY by Medcare Custom Packaging, Inc. — Product Code FCM

K950390 is an FDA 510(k) premarket notification submitted by Medcare Custom Packaging, Inc. for the device "URETHRAL CATHETERIZATION TRAY". The FDA issued a decision of Substantially Equivalent on May 30, 1995. 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. Medcare Custom Packaging, Inc. has at least 10 other 510(k) clearances on record.