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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 K192280
Device Name PENTAX Medical ED-3490TK Video Duodenoscope
Applicant
Pentax Medical
3 Paragon Drive
Montvale,  NJ  07645
Applicant Contact William Goeller
Correspondent
Pentax Medical
3 Paragon Drive
Montvale,  NJ  07645
Correspondent Contact William Goeller
Regulation Number876.1500
Classification Product Code
FDT  
Date Received08/22/2019
Decision Date 10/21/2019
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
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