FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)

FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) is an FDA 510(k)-cleared medical device (K964055) manufactured by Epic Medical Equipment Services, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 1997. Regulation: 8.