MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)

MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) is an FDA 510(k)-cleared medical device (K053636) 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 March 13, 2006. Regulation: 8.