FDA 510(k), K143380, Phasix ST Mesh

FDA 510(k), K143380, Phasix ST Mesh

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510(K) Number: K143380
Device Name: Phasix ST Mesh
Manufacturer: C. R. Bard Inc
Device Classification Name: mesh, surgical, absorbable, abdominal hernia
Regulation Number: 878.3300
Classification Product Code: OWT
Date Received: 11/25/2014
Decision Date: 06/05/2015
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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