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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 K161222
Device Name PENTAX MEDICAL ED-3490TK, Video Duodenoscope
Applicant
PENTAX MEDICAL
3 PARAGON DRIVE
MONTVALE,  NJ  07645
Applicant Contact KANCHANA IYER
Correspondent
PENTAX MEDICAL
3 PARAGON DRIVE
MONTVALE,  NJ  07645
Correspondent Contact William Goeller
Regulation Number876.1500
Classification Product Code
FDT  
Date Received04/29/2016
Decision Date 02/07/2018
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
Recalls CDRH Recalls
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