FDA 510(k) Application Details - K230469

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K230469
Device Name	Pump, Breast, Powered
Applicant	Lansinoh Laboratories 99 Canal Center Plaza, Suite 550 Alexandria, VA 22314 US Other 510(k) Applications for this Company
Contact	Lindsay Ewers 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	02/21/2023
Decision Date	06/30/2023
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