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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evacuator, Gastro-Urology
510(k) Number K921088
Device Name EVACUATOR, GASTRO-UROLOGY
Applicant
Northgate Technologies, Inc.
3930 Ventura Dr.
Arlington Heights,  IL  60004
Applicant Contact DANIEL KAMM
Correspondent
Northgate Technologies, Inc.
3930 Ventura Dr.
Arlington Heights,  IL  60004
Correspondent Contact DANIEL KAMM
Regulation Number876.4370
Classification Product Code
KQT  
Date Received03/06/1992
Decision Date 10/28/1992
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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