510(k) K003784

MENTOR SELF-CATH PLUS by Mentor Corp. — Product Code EZL

K003784 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MENTOR SELF-CATH PLUS". The FDA issued a decision of Substantially Equivalent on March 5, 2001. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Mentor Corp. has at least 10 other 510(k) clearances on record.