FDA 510(k), K090858, PARIETEX MONOFILAMENT POLYESTER MESH

FDA 510(k), K090858, PARIETEX MONOFILAMENT POLYESTER MESH

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510(K) Number: K090858
Device Name: PARIETEX MONOFILAMENT POLYESTER MESH
Manufacturer: ANGELA BUNN
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: KXA
Date Received: 03/30/2009
Decision Date: 05/06/2009
Decision: Substantially Equivalent (SESE)
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

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