SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT

SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT is an FDA 510(k)-cleared medical device (K870518) manufactured by Surgitek. 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 April 28, 1987. Regulation: 8.