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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 K001325
Device Name FLO ASSISTANT, MODEL 4-250-00
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 Number876.5130
Classification Product Code
LJH  
Date Received04/26/2000
Decision Date 08/18/2000
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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