FDA 510(k) Application Details - K250838

Device Classification Name	Microtools, Assisted Reproduction (Pipettes)   More FDA Info for this Device
510(K) Number	K250838
Device Name	Microtools, Assisted Reproduction (Pipettes)
Applicant	Guangzhou PINZHI Medical Device Co., Ltd. Room 405, 4th Floor, No.600-2 Guangshan 2nd Road Fenghuang Street, Tianhe District Guangzhou 510520 CN Other 510(k) Applications for this Company
Contact	Hestia Xu Other 510(k) Applications for this Contact
Regulation Number	884.6130   More FDA Info for this Regulation Number
Classification Product Code	MQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2025
Decision Date	07/03/2025
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