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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K930912
Device Name HYSTEROMED 100
Applicant
Northgate Technologies, Inc.
3930 Ventura Dr.
Arlington Heights,  IL  60004
Applicant Contact KENNETH SIKORA
Correspondent
Northgate Technologies, Inc.
3930 Ventura Dr.
Arlington Heights,  IL  60004
Correspondent Contact KENNETH SIKORA
Regulation Number884.1700
Classification Product Code
HIG  
Date Received02/22/1993
Decision Date 10/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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