FDA 510(k) Application Details - K112975

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K112975
Device Name	Insufflator, Laparoscopic
Applicant	CARDIA INNOVATION AB 7307 GLOCHESTER DRIVE EDINA, MN 55435 US Other 510(k) Applications for this Company
Contact	JEFFREY R SHIDEMAN Other 510(k) Applications for this Contact
Regulation Number	884.1730   More FDA Info for this Regulation Number
Classification Product Code	HIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2011
Decision Date	06/22/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review