FDA 510(k) Application Details - K050197

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K050197
Device Name	Accessory, Assisted Reproduction
Applicant	MINITUBE OF AMERICA, INC ONE EAST MAIN STREET, STE 300 MADISON, WI 53703 US Other 510(k) Applications for this Company
Contact	FREDERICK T RIKKERS Other 510(k) Applications for this Contact
Regulation Number	884.6120   More FDA Info for this Regulation Number
Classification Product Code	MQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2005
Decision Date	10/06/2006
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