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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
Original Applicant
CARDIA INNOVATION AB
7307 glochester drive
edina,  MN  55435
Original 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 Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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