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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name colonoscope and accessories, flexible/rigid
510(k) Number K180285
Device Name PENTAX Medical Video Colonoscope EC34-i10T Series
Applicant
PENTAX Medical of America, Inc
3 Paragon Drive
Montvale,  NJ  07645 -1782
Applicant Contact James W. Monroe
Correspondent
PENTAX Medical of America, Inc
3 Paragon Drive
Montvale,  NJ  07645 -1782
Correspondent Contact James W. Monroe
Regulation Number876.1500
Classification Product Code
FDF  
Date Received02/01/2018
Decision Date 10/26/2018
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
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