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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 K993778
Device Name HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
Applicant
Northgate Technologies, Inc.
600 Church Rd.
Elgin,  IL  60123
Applicant Contact CASEY KUREK
Correspondent
Northgate Technologies, Inc.
600 Church Rd.
Elgin,  IL  60123
Correspondent Contact CASEY KUREK
Regulation Number876.1500
Classification Product Code
OCX  
Date Received11/08/1999
Decision Date 01/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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