FDA 510(k), K210710, PENTAX Medical Video Duedenoscope ED34-i10T2

FDA 510(k), K210710, PENTAX Medical Video Duedenoscope ED34-i10T2

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510(K) Number: K210710
Device Name: PENTAX Medical Video Duedenoscope ED34-i10T2
Manufacturer: PENTAX of America, Inc.
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FDT
Date Received: 03/10/2021
Decision Date: 04/09/2021
Regulation Medical Specialty: Gastroenterology/Urology
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