FDA 510(k), K091510, WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730

FDA 510(k), K091510, WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730

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510(K) Number: K091510
Device Name: WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
Manufacturer: Boston Scientific Corporation
Device Classification Name: prosthesis, esophageal
Regulation Number: 878.3610
Classification Product Code: ESW
Date Received: 05/22/2009
Decision Date: 06/26/2009
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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