FDA 510(k) Application Details - K162640

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K162640
Device Name	Labware, Assisted Reproduction
Applicant	REPROBITECH CORP. 27 HADDON RD New Hyde Park, NY 11040 US Other 510(k) Applications for this Company
Contact	Huai L. Feng 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	09/22/2016
Decision Date	06/30/2017
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