FDA 510(k) Application Details - K192845

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K192845
Device Name	Media, Reproductive
Applicant	Kitazato Corporation 81 Nakajima Fuji Shizuoka 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	10/03/2019
Decision Date	08/17/2020
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