TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM

TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K042712) 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 October 14, 2004. Regulation: 8.