FDA 510(k) Application Details - K133295

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K133295
Device Name	Labware, Assisted Reproduction
Applicant	MENICON CO., LTD. NEW BUSINESS DIVISION 4050 OLSON MEMORIAL HWY, SUITE 450 MINNEAPOLIS, MN 55422 US Other 510(k) Applications for this Company
Contact	MARCIA PALMA Other 510(k) Applications for this Contact
Regulation Number	884.6160   More FDA Info for this Regulation Number
Classification Product Code	MQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2013
Decision Date	06/18/2014
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