
Baxa Corp., Sub. of Cook Group, Inc.
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TWOFER NEEDLE is an FDA 510(k)-cleared medical device (K832347) manufactured by Baxa Corp., Sub. of Cook Group, Inc.. 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 September 11, 1983. Regulation: 8.

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