PRESS TACK NEEDLE

PRESS TACK NEEDLE is an FDA 510(k)-cleared medical device (K042063) manufactured by Asia-Med GmbH & Co. Kg. - Werk Suhl. 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 October 13, 2004. Regulation: 8.