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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name duodenoscope and accessories, flexible/rigid
510(k) Number K163614
FOIA Releasable 510(k) K163614
Device Name PENTAX Medical ED34-i10T, Video Duodenoscope
PENTAX Medical
3 Paragon Drive
Montvale,  NJ  07645
Applicant Contact Kanchana Iyer
PENTAX Medical
3 Paragon Drive
Montvale,  NJ  07645
Correspondent Contact Kanchana Iyer
Regulation Number876.1500
Classification Product Code
Date Received12/22/2016
Decision Date 09/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No