
Gallini U.S., LLC
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GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE is an FDA 510(k)-cleared medical device (K992499) 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 August 11, 1999. Regulation: 8.