FDA 510(k) Application Details - K971231

Device Classification Name	Pump, Breast, Non-Powered   More FDA Info for this Device
510(K) Number	K971231
Device Name	Pump, Breast, Non-Powered
Applicant	WHITE RIVER CONCEPTS 924 CALLE NEGOCIO, UNIT C SAN CLEMENTE, CA 92673 US Other 510(k) Applications for this Company
Contact	E.J. Smith 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	04/03/1997
Decision Date	05/19/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review