FDA 510(k) Application Details - K182749

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K182749
Device Name	Pump, Breast, Powered
Applicant	Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd Sti. 10006 sok. No: 64 AOSB Cigli 35620 TR 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	09/28/2018
Decision Date	06/12/2019
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