DOBBHOFF(R) SINGLE PASS PEG KIT

DOBBHOFF(R) SINGLE PASS PEG KIT is an FDA 510(k)-cleared medical device (K913784) manufactured by Biosearch Medical Products, 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 January 14, 1992. Regulation: 8.