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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 K192245
Device Name Pentax Medical Video Duodenoscope ED34-i10T2
Applicant
PENTAX of America, Inc.
3 Paragon Drive
montvale,  NJ  07645 -1782
Applicant Contact william goeller
Correspondent
PENTAX of America, Inc.
3 Paragon Drive
montvale,  NJ  07645 -1782
Correspondent Contact william goeller
Regulation Number876.1500
Classification Product Code
FDT  
Date Received08/19/2019
Decision Date 11/15/2019
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
Recalls CDRH Recalls
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