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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 K120151
FOIA Releasable 510(k) K120151
Device Name NEBULAE I
Applicant
Northgate Technologies, Inc.
1591 Scottsdale Court
Elgin,  IL  60123
Applicant Contact CASEY KUREK
Correspondent
Northgate Technologies, Inc.
1591 Scottsdale Court
Elgin,  IL  60123
Correspondent Contact CASEY KUREK
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Codes
FCX   OSV  
Date Received01/18/2012
Decision Date 08/17/2012
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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