510(k) K941692

FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER by Rochester Medical Corp. — Product Code EZL

K941692 is an FDA 510(k) premarket notification submitted by Rochester Medical Corp. for the device "FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER". The FDA issued a decision of Substantially Equivalent on March 6, 1995. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Rochester Medical Corp. has at least 10 other 510(k) clearances on record.