SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER

SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER is an FDA 510(k)-cleared medical device (K821394) manufactured by Kleen Test Products. 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 June 2, 1982. Regulation: 8.