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FDA 510(k), K162749, FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
FDA 510(k), K162749, FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
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510(K) Number: K162749
Device Name: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
Manufacturer: FUJIFILM Medical Systems U.S.A., Inc.
Device Classification Name: gastroscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDS
Date Received: 09/30/2016
Decision Date: 06/15/2017
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
Manufacturer: FUJIFILM Medical Systems U.S.A., Inc.
Device Classification Name: gastroscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDS
Date Received: 09/30/2016
Decision Date: 06/15/2017
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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