FDA 510(k) Application Details - K153367

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K153367
Device Name	Insufflator, Laparoscopic
Applicant	SOPRO - ACTEON GROUP ZAC ATHELIA IV AVENUE DES GENEVRIERS LA CIOTAT 13705 FR Other 510(k) Applications for this Company
Contact	Philippe BOYER 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	11/23/2015
Decision Date	06/17/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review