FDA 510(k), K142706, Modified ONFLEX Mesh

FDA 510(k), K142706, Modified ONFLEX Mesh

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510(K) Number: K142706
Device Name: Modified ONFLEX Mesh
Manufacturer: C.R. Bard Inc.
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 09/22/2014
Decision Date: 03/25/2015
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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