510(k) K041464

BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER by Busse Hospital Disposables — Product Code EZD

K041464 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables for the device "BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER". The FDA issued a decision of Substantially Equivalent on November 5, 2004. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Busse Hospital Disposables has at least 10 other 510(k) clearances on record.