TEMNO DOUBLE SHOT BIOPSY NEEDLE

TEMNO DOUBLE SHOT BIOPSY NEEDLE is an FDA 510(k)-cleared medical device (K960065) manufactured by Bauer 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 April 4, 1996. Regulation: 8.