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FDA 510(k), K092710, PENTAX ED-3490TK, VIDEO DUODENOSCOPE
FDA 510(k), K092710, PENTAX ED-3490TK, VIDEO DUODENOSCOPE
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510(K) Number: K092710
Device Name: PENTAX ED-3490TK, VIDEO DUODENOSCOPE
Manufacturer: PENTAX MEDICAL COMPANY
Device Classification Name: duodenoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDT
Date Received: 09/03/2009
Decision Date: 12/02/2009
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PENTAX ED-3490TK, VIDEO DUODENOSCOPE
Manufacturer: PENTAX MEDICAL COMPANY
Device Classification Name: duodenoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDT
Date Received: 09/03/2009
Decision Date: 12/02/2009
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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