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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological
510(k) Number K970717
Device Name VAPOR-TECH SLED ELECTRODE
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 Number876.4300
Classification Product Code
FAS  
Date Received02/27/1997
Decision Date 05/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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