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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 K935862
Device Name NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600
Applicant
NORTHGATE TECHNOLOGIES, INC.
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact ROBERT R MANTELL
Correspondent
NORTHGATE TECHNOLOGIES, INC.
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact ROBERT R MANTELL
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/03/1993
Decision Date 08/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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