FDA 510(k), K992510, WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM

FDA 510(k), K992510, WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM

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510(K) Number: K992510
Device Name: WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: prosthesis, tracheal, expandable
Regulation Number: 878.3720
Classification Product Code: JCT
Date Received: 07/27/1999
Decision Date: 11/18/1999
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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