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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 K033695
Device Name IRRIGATION CHANNEL TUBING, MODEL 100135
Applicant
Byrne Medical, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071
Applicant Contact J. HARVEY KNAUSS
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact N.E. DEVINE
Regulation Number876.1500
Classification Product Code
OCX  
Date Received11/25/2003
Decision Date 12/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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