MRI'S ALL SILICONE FOLEY CATHETER

MRI'S ALL SILICONE FOLEY CATHETER is an FDA 510(k)-cleared medical device (K944676) manufactured by Mri Manufacturing and Research, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 4, 1996. Regulation: 8.