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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 K010122
Device Name CONTINUOUS FLOW Y-TUBING
Applicant
G.U.-Tek
904 Oak Tree Ave.
South Plainfield,  NJ  07080
Applicant Contact ANTHONY SOLAZZO
Correspondent
G.U.-Tek
904 Oak Tree Ave.
South Plainfield,  NJ  07080
Correspondent Contact ANTHONY SOLAZZO
Regulation Number876.5130
Classification Product Code
LJH  
Date Received01/16/2001
Decision Date 06/04/2001
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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