FDA 510(k) Application Details - K112396

Device Classification Name	Catheter, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K112396
Device Name	Catheter, Assisted Reproduction
Applicant	KITAZATO MEDICAL CO., LTD. 611 WEST 5TH STREET AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	RICHARD VINCINS 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	08/19/2011
Decision Date	11/02/2012
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