
Gallini U.S., LLC
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GALLINI BYCUT NEEDLE is an FDA 510(k)-cleared medical device (K990716) manufactured by Gallini U.S., 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 May 16, 1999. Regulation: 8.