510(k) K950344

HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER by Acacia Laboratories, Inc. — Product Code FCM

K950344 is an FDA 510(k) premarket notification submitted by Acacia Laboratories, Inc. for the device "HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 24, 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. Acacia Laboratories, Inc. has at least 10 other 510(k) clearances on record.