FDA 510(k) Application Details - K200408

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K200408
Device Name	Media, Reproductive
Applicant	Shenzhen VitaVitro Biotech Co.,Ltd. R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No. 16 Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	Donghai Pan 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	02/19/2020
Decision Date	10/16/2020
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