TACKER, MODEL R65-933

TACKER, MODEL R65-933 is an FDA 510(k)-cleared medical device (K003949) manufactured by A & A Medical, 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 July 24, 2001. Regulation: 8.