FDA 510(k) Application Details - K203570

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K203570
Device Name	Pump, Breast, Powered
Applicant	Ameda, Inc. 485 Half Day Road; Suite 320 Buffalo Grove, IL 60089 US Other 510(k) Applications for this Company
Contact	Carolin Archibald 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	12/07/2020
Decision Date	04/22/2021
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