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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 K954710
Device Name VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
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 Received10/12/1995
Decision Date 04/24/1996
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
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