FDA 510(k) Application Details - K031622

Device Classification Name	Needle, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K031622
Device Name	Needle, Assisted Reproduction
Applicant	PORTEX LTD. MILITARY ROAD HYTHE, KENT ENGLAND CT21 6DB GB Other 510(k) Applications for this Company
Contact	STEVE OGILVIE Other 510(k) Applications for this Contact
Regulation Number	884.6100   More FDA Info for this Regulation Number
Classification Product Code	MQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2003
Decision Date	06/26/2003
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