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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastroscope and accessories, flexible/rigid
510(k) Number K210485
Device Name PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)
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
FDS  
Subsequent Product Code
FDF  
Date Received02/19/2021
Decision Date 05/13/2021
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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