510(k) K000723

HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) by Rochester Medical Corp. — Product Code KOD

K000723 is an FDA 510(k) premarket notification submitted by Rochester Medical Corp. for the device "HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)". The FDA issued a decision of Substantially Equivalent on May 19, 2000. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Rochester Medical Corp. has at least 10 other 510(k) clearances on record.