FDA 510(k) Application Details - K191015

Device Classification Name	Catheter, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K191015
Device Name	Catheter, Assisted Reproduction
Applicant	Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 US Other 510(k) Applications for this Company
Contact	Ian Herrman Other 510(k) Applications for this Contact
Regulation Number	884.6110   More FDA Info for this Regulation Number
Classification Product Code	MQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2019
Decision Date	05/17/2019
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