MAXCESS NEEDLEFREE - Y- SITE (100713)

MAXCESS NEEDLEFREE - Y- SITE (100713) is an FDA 510(k)-cleared medical device (K970800) manufactured by Solopak Medical Products, 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 April 1, 1997. Regulation: 8.