FDA 510(k) Application Details - K011519

Device Classification Name	Pump, Breast, Non-Powered   More FDA Info for this Device
510(K) Number	K011519
Device Name	Pump, Breast, Non-Powered
Applicant	HOLLISTER, INC. 2000 HOLLISTER DR. LIBERTYVILLE, IL 60048 US Other 510(k) Applications for this Company
Contact	JOSEPH S TOKARZ Other 510(k) Applications for this Contact
Regulation Number	884.5150   More FDA Info for this Regulation Number
Classification Product Code	HGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2001
Decision Date	08/15/2001
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