FDA 510(k) Application Details - K191653

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K191653
Device Name	Pump, Breast, Powered
Applicant	Medela AG Laettichstrasse 4b Baar Zug CH-6341 CH Other 510(k) Applications for this Company
Contact	Judith Bernardo 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	06/20/2019
Decision Date	10/17/2019
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