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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 K010053
Device Name HUMI-FLOW, MODEL 6-850-00/ 01/02
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 Received01/08/2001
Decision Date 10/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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