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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K041560
Device Name FLO-ASSISTANT
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 Number884.1730
Classification Product Code
HIF  
Date Received06/10/2004
Decision Date 09/28/2004
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
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