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FDA 510(k) K082750, ENTACT SEPTAL STAPLER, MODEL 610-00100, by Entrigue Surgical, Inc.

FDA 510(k) K082750, ENTACT SEPTAL STAPLER, MODEL 610-00100, by Entrigue Surgical, Inc.

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510(K) Number: K082750
Device Name: ENTACT SEPTAL STAPLER, MODEL 610-00100
Manufacturer: Entrigue Surgical, Inc.
Device Classification Name: septal stapler/absorbable staples
Regulation Number: 878.4750
Classification Product Code: OLL
Date Received: 09/19/2008
Decision Date: 01/06/2009
Regulation Medical Specialty: General & Plastic Surgery
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