FDA 510(k) Application Details - K123258

Device Classification Name	Cannula, Manipulator/Injector, Uterine   More FDA Info for this Device
510(K) Number	K123258
Device Name	Cannula, Manipulator/Injector, Uterine
Applicant	CATHETER RESEARCH, INC. 5610 W 82ND ST INDIANAPOLIS, IN 46278 US Other 510(k) Applications for this Company
Contact	BABACAR DIOUF 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	10/18/2012
Decision Date	01/31/2013
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