510(k) K050008

MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER by Mentor Corp. — Product Code EZD

K050008 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER". The FDA issued a decision of Substantially Equivalent on June 3, 2005. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Mentor Corp. has at least 10 other 510(k) clearances on record.