MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT

MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT is an FDA 510(k)-cleared medical device (K050770) manufactured by Mckinley Medical, LLC. 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 13, 2005. Regulation: 8.