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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 K131902
Device Name PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
Applicant
Pentax Medical Company
3 Paragon Dr.
Montvale,  NJ  07645
Applicant Contact KRISHNA GOVINDARAJAN
Correspondent
Pentax Medical Company
3 Paragon Dr.
Montvale,  NJ  07645
Correspondent Contact KRISHNA GOVINDARAJAN
Regulation Number876.1500
Classification Product Code
FDS  
Date Received06/25/2013
Decision Date 04/10/2014
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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