FDA 510(k) Application Details - K132203

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K132203
Device Name	Insufflator, Laparoscopic
Applicant	LEXION MEDICAL, LLC. 4486 TIMBERLINE CT VADNAIS HEIGHTS, MN 55127 US Other 510(k) Applications for this Company
Contact	BERNARD HORWATH 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	07/16/2013
Decision Date	09/20/2013
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