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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 K112975
Device Name CARBONAID C02 DIFFUSER
Applicant
Cardia Innovation AB
7307 Glochester Dr.
Edina,  MN  55435
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Cardia Innovation AB
7307 Glochester Dr.
Edina,  MN  55435
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received10/05/2011
Decision Date 06/22/2012
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
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