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FDA 510(k) K140516, Terumo Pen Injector Needle 34, by Kofu Factory of Terumo Corp.

FDA 510(k) K140516, Terumo Pen Injector Needle 34, by Kofu Factory of Terumo Corp.

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510(K) Number: K140516
Device Name: Terumo Pen Injector Needle 34
Manufacturer: Kofu Factory of Terumo Corp.
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 02/28/2014
Decision Date: 08/05/2014
Regulation Medical Specialty: General Hospital
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