ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)

ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) is an FDA 510(k)-cleared medical device (K011369) manufactured by Safety Syringes, Inc.. 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 May 28, 2001. Regulation: 8.