FDA 510(k), K930822, GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH

FDA 510(k), K930822, GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH

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510(K) Number: K930822
Device Name: GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
Manufacturer: LARRY PRATT
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: KXA
Date Received: 02/17/1993
Decision Date: 01/28/1994
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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