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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope
510(k) Number K113310
Device Name ENDOGATER AVANTAGE CO2 INSUFFLATOR
Applicant
BYRNE MEDICAL, INC.
14605 28TH AVENUE NORTH
MINNEAPOLIS,  MN  55442
Applicant Contact Brent Geiger
Correspondent
BYRNE MEDICAL, INC.
14605 28TH AVENUE NORTH
MINNEAPOLIS,  MN  55442
Correspondent Contact Brent Geiger
Regulation Number876.1500
Classification Product Code
FCX  
Date Received11/08/2011
Decision Date 06/20/2012
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
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