SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S

SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S is an FDA 510(k)-cleared medical device (K022099) manufactured by Hdc 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 September 19, 2002. Regulation: 8.