
Depuy Mitek, A Johnson & Johnson Company
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PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE is an FDA 510(k)-cleared medical device (K042233) manufactured by Depuy Mitek, A Johnson & Johnson Company. 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 September 27, 2004. Regulation: 8.