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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 K911179
Device Name VERRES NEEDLES 5 & 6 INCHES
Applicant
Northgate Technologies, Inc.
3930 Ventura Dr.
Arlington Heights,  IL  60004
Applicant Contact SAMUELLA D EMRICH
Correspondent
Northgate Technologies, Inc.
3930 Ventura Dr.
Arlington Heights,  IL  60004
Correspondent Contact SAMUELLA D EMRICH
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/18/1991
Decision Date 11/13/1991
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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