FDA 510(k) Application Details - K230570

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K230570
Device Name	Pump, Breast, Powered
Applicant	Willow Innovations, Inc. 1975 W. El Camino Real, Suite 306 Mountain View, CA 94040 US Other 510(k) Applications for this Company
Contact	Shruti Jayakumar 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	03/01/2023
Decision Date	10/16/2023
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