FDA 510(k) Application Details - K242561

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K242561
Device Name	Media, Reproductive
Applicant	DonneVie Medical Technology (Shanghai) Co. Ltd. Suite 201, Bld. 1, 138 Xinjun Ring Minhang District Shanghai 201114 CN Other 510(k) Applications for this Company
Contact	Hannah Hang Yin 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	08/28/2024
Decision Date	04/10/2025
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