FDA 510(k), K003990, SOFRADIM PARIETEX SURGICAL MESHES

FDA 510(k), K003990, SOFRADIM PARIETEX SURGICAL MESHES

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510(K) Number: K003990
Device Name: SOFRADIM PARIETEX SURGICAL MESHES
Manufacturer: MARY MCNAMARA-CULLINANE
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: KXA
Date Received: 12/26/2000
Decision Date: 01/24/2001
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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