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Seikagaku Corp.
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HADGEL, 4 GRAM/SYRINGE is an FDA 510(k)-cleared medical device (K011544) manufactured by Seikagaku Corp.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 14, 2001. Regulation: 8.

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