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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K113119
Device Name ENDOGATOR ADVANTAGE IRRIGATION PUMP
Applicant
Byrne Medical, Inc.
14605 28th Ave. N.
Minneapolis,  MN  55442
Applicant Contact Brent Geiger
Correspondent
Byrne Medical, Inc.
14605 28th Ave. N.
Minneapolis,  MN  55442
Correspondent Contact Brent Geiger
Regulation Number876.1500
Classification Product Code
OCX  
Date Received10/21/2011
Decision Date 04/27/2012
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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