FDA 510(k) Application Details - K160863

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K160863
Device Name	Media, Reproductive
Applicant	KITAZATO BIOPHARMA CO., LTD. 81 NAKIJIMA FUJI 416-0907 JP Other 510(k) Applications for this Company
Contact	FUTOSHI INOUE Other 510(k) Applications for this Contact
Regulation Number	884.6180   More FDA Info for this Regulation Number
Classification Product Code	MQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2016
Decision Date	07/28/2016
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