FDA 510(k) Application Details - K232163

Device Classification Name	Needle, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K232163
Device Name	Needle, Assisted Reproduction
Applicant	Zhejiang Horizon Medical Technology Co., Ltd. Room 219, 2nd floor, Building 9, 1303 Asia-Pacific Road Daqiao Town, Nanhu District Jiaxing 314006 CN Other 510(k) Applications for this Company
Contact	Wu Tang Other 510(k) Applications for this Contact
Regulation Number	884.6100   More FDA Info for this Regulation Number
Classification Product Code	MQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2023
Decision Date	02/22/2024
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