ISLAND BIOSURGICAL BNS KIT #3

ISLAND BIOSURGICAL BNS KIT #3 is an FDA 510(k)-cleared medical device (K001583) manufactured by Island Biosurgical, LLC. 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 12, 2000. Regulation: 8.