FDA 510(k) Application Details - K082307

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K082307
Device Name	Pump, Breast, Powered
Applicant	EVENFLO COMPANY, INC. 225 BYERS RD. MIAMISBURG, OH 45342 US Other 510(k) Applications for this Company
Contact	AMY NEFF 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	08/13/2008
Decision Date	09/11/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review