LUTH-ALL SUB-Q NEEDLE SET

LUTH-ALL SUB-Q NEEDLE SET is an FDA 510(k)-cleared medical device (K042666) manufactured by Luth-All Medical Products, 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 December 20, 2004. Regulation: 8.