
Mani, Inc.
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MANI NEEDLE & SUTURE PACK (NYLON) is an FDA 510(k)-cleared medical device (K053637) 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 May 18, 2006. Regulation: 8.