MANI NEEDLE & SUTURE PACK

MANI NEEDLE & SUTURE PACK is an FDA 510(k)-cleared medical device (K050150) manufactured by Mani, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2005. Regulation: 8.