510(k) K082831

AMSELF CLOSED CATHETERIZATION SYSTEM by Amsino International, Inc. — Product Code FCM

K082831 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSELF CLOSED CATHETERIZATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 23, 2008. 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. Amsino International, Inc. has at least 10 other 510(k) clearances on record.