FDA 510(k) Application Details - K162051

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K162051
Device Name	Labware, Assisted Reproduction
Applicant	REPROLIFE INC. 2-5-5-8F, SHINJUKU SHINJUKU-KU 160-0022 JP Other 510(k) Applications for this Company
Contact	KOICHI TAKEDA 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	07/25/2016
Decision Date	12/14/2016
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