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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K943361
Device Name NORTHGATE FLOW ASSIST TUBING FOR UROLOGY
Applicant
NORTHGATE TECHNOLOGIES, INC.
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact CASEY KUREK
Correspondent
NORTHGATE TECHNOLOGIES, INC.
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact CASEY KUREK
Regulation Number876.5130
Classification Product Code
LJH  
Date Received07/13/1994
Decision Date 09/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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