NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO

NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO is an FDA 510(k)-cleared medical device (K925161) manufactured by North American Sterilization & Packaging Co.. 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 July 20, 1993. Regulation: 8.