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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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