FDA 510(k) Application Details - K234088

Device Classification Name	More FDA Info for this Device
510(K) Number	K234088
Device Name	Emily's Care Nourish Test System (Model 1)
Applicant	Lactation Lab Inc. 2611 Palm Avenue Manhattan Beach, CA 90266 US Other 510(k) Applications for this Company
Contact	Stephanie Canale Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2023
Decision Date	05/03/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review