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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device septal stapler/absorbable staples
Regulation Description Implantable staple.
Definition To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction.
Product CodeOLL
Regulation Number 878.4750
Device Class 2


Premarket Reviews
ManufacturerDecision
ENTRIGUE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

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