FDA 510(k) Application Details - K220010

Device Classification Name	Catheter, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K220010
Device Name	Catheter, Assisted Reproduction
Applicant	Shanghai Horizon Medical Technology Co., Ltd. Room 401, Building #24, No. 1-28, 588 Tianxiong Rd Pudong New Area Shanghai 201318 CN Other 510(k) Applications for this Company
Contact	Beibei Xing Other 510(k) Applications for this Contact
Regulation Number	884.6110   More FDA Info for this Regulation Number
Classification Product Code	MQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2022
Decision Date	12/16/2022
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