510(k) K070939

SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM by Coloplast Manufacturing Us, LLC — Product Code FCM

K070939 is an FDA 510(k) premarket notification submitted by Coloplast Manufacturing Us, LLC for the device "SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 1, 2007. 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. Coloplast Manufacturing Us, LLC has at least 3 other 510(k) clearances on record.