510(k) K971627

SILICONE ANTIBACTERIAL FOLEY CATHETER by Rochester Medical Corp. — Product Code MJC

K971627 is an FDA 510(k) premarket notification submitted by Rochester Medical Corp. for the device "SILICONE ANTIBACTERIAL FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on January 13, 1998. The device falls under product code MJC (Catheter, Urological (Antimicrobial) And Accessories), a Class II device regulated under 21 CFR 876.5130. Rochester Medical Corp. has at least 10 other 510(k) clearances on record.