ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER

ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER is an FDA 510(k)-cleared medical device (K952082) manufactured by Rochester Medical Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 17, 1995. Regulation: 8.