FDA 510(k) Application Details - K230672

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K230672
Device Name	Pump, Breast, Powered
Applicant	Annabella Ltd. 23/5 Hataas KFAR SABA 4442525 IL Other 510(k) Applications for this Company
Contact	Uri Yaffe Other 510(k) Applications for this Contact
Regulation Number	884.5160   More FDA Info for this Regulation Number
Classification Product Code	HGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2023
Decision Date	08/04/2023
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