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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 K102855
Device Name UNIVERSAL IRRIGATION SOLUTION HYBRID
Applicant
Byrne Medical, Inc.
3150 Pollock Dr.
Conroe,  TX  77303
Applicant Contact JOHN WILLIS
Correspondent
Byrne Medical, Inc.
3150 Pollock Dr.
Conroe,  TX  77303
Correspondent Contact JOHN WILLIS
Regulation Number876.1500
Classification Product Code
OCX  
Date Received09/29/2010
Decision Date 11/19/2010
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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