FDA 510(k) Application Details - K091366

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K091366
Device Name	Insufflator, Laparoscopic
Applicant	LEXION MEDICAL, LLC. 5000 TOWNSHIP PKWY ST. PAUL, MN 55110 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	05/08/2009
Decision Date	09/03/2009
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