FDA 510(k) Application Details - K160504

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K160504
Device Name	Accessory, Assisted Reproduction
Applicant	RESEARCH INSTRUMENTS LIMITED BICKLAND INDUSTRIAL PARK FALMOUTH TR11 4TA GB Other 510(k) Applications for this Company
Contact	Wendy Hassan Other 510(k) Applications for this Contact
Regulation Number	884.6120   More FDA Info for this Regulation Number
Classification Product Code	MQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2016
Decision Date	07/18/2016
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