510(k) K896212

URETHRAL CATHETERIZATION TRAYS by Westmark, Sterile Packing Systems, Inc. (Sps) — Product Code FCM

K896212 is an FDA 510(k) premarket notification submitted by Westmark, Sterile Packing Systems, Inc. (Sps) for the device "URETHRAL CATHETERIZATION TRAYS". The FDA issued a decision of Substantially Equivalent (with conditions) on January 24, 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. Westmark, Sterile Packing Systems, Inc. (Sps) has at least 10 other 510(k) clearances on record.