FDA 510(k) Application Details - K092783

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K092783
Device Name	Pump, Breast, Powered
Applicant	ENKO LTD. 10006 SOKAK, NO.64, A.O.S.B. CIGLI - IZMIR 35620 TR Other 510(k) Applications for this Company
Contact	SINAN KAZAZOGLU 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	09/10/2009
Decision Date	10/22/2009
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	Y
Expedited Review