
Kofu Factory of Terumo Corp.
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Terumo Pen Injector Needle 34 is an FDA 510(k)-cleared medical device (K140516) manufactured by Kofu Factory of Terumo Corp.. 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 August 4, 2014. Regulation: 8.

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