FDA 510(k) Application Details - K181770

Device Classification Name	Cannula, Manipulator/Injector, Uterine   More FDA Info for this Device
510(K) Number	K181770
Device Name	Cannula, Manipulator/Injector, Uterine
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	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2018
Decision Date	03/29/2019
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