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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K962271
Device Name ELECTROSURGICAL ELECRTRODES
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 Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
HGI  
Date Received06/13/1996
Decision Date 08/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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