FDA 510(k) Application Details - K170799

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K170799
Device Name	Insufflator, Laparoscopic
Applicant	LEXION Medical LLC 545 Atwater Circle St Paul, MN 55103 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	03/17/2017
Decision Date	11/14/2017
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