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

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