FDA 510(k) Application Details - K191291

Device Classification Name	Needle, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K191291
Device Name	Needle, Assisted Reproduction
Applicant	CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 US Other 510(k) Applications for this Company
Contact	Christine Kupchick Other 510(k) Applications for this Contact
Regulation Number	884.6100   More FDA Info for this Regulation Number
Classification Product Code	MQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2019
Decision Date	06/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review