STERILE EMPTY PCA SYRINGE

STERILE EMPTY PCA SYRINGE is an FDA 510(k)-cleared medical device (K945797) manufactured by Intl. Medication Systems, Ltd.. 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 18, 1995. Regulation: 8.