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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 K213773
Device Name Insufflation Retention Device
Applicant
Bpendo, LLC
216 Foreman Circle
Norman,  OK  73069
Applicant Contact Robert Holbrook
Correspondent
Gilero, LLC
635 Davis Drive STE 100
Morrisville,  NC  27560
Correspondent Contact James Fentress
Regulation Number876.1500
Classification Product Code
FDF  
Date Received12/02/2021
Decision Date 07/21/2022
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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