FDA 510(k), K040048, FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM

FDA 510(k), K040048, FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM

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510(K) Number: K040048
Device Name: FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
Manufacturer: FUJINON, INC.
Device Classification Name: enteroscope and accessories
Regulation Number: 876.1500
Classification Product Code: FDA
Date Received: 01/12/2004
Decision Date: 06/07/2004
Regulation Medical Specialty: Gastroenterology/Urology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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