E.N.S.I. SYRINGE

E.N.S.I. SYRINGE is an FDA 510(k)-cleared medical device (K000572) manufactured by Tri-Ject Intl. Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2000. Regulation: 8.