
Gastrotech, Inc.
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SYRINGE INJECTION GUN DELIVERY KITS is an FDA 510(k)-cleared medical device (K890658) manufactured by Gastrotech, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 1989. Regulation: 8.