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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 K031773
Device Name ENDO GATOR SYSTEM
Applicant
Byrne Medical, Inc.
11874 S. Evelyn Cir.
Houston,  TX  77071
Applicant Contact J. HARVEY KNAUSS
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number876.1500
Classification Product Code
OCX  
Date Received06/09/2003
Decision Date 06/24/2003
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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