FDA 510(k) Application Details - K053208

Device Classification Name	Catheter, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K053208
Device Name	Catheter, Assisted Reproduction
Applicant	SWEMED LAB INTERNATIONAL AB BILLDALSVAGEN 2 BILLDAL SE-427 36 SE Other 510(k) Applications for this Company
Contact	ANDERS JOHANSSON Other 510(k) Applications for this Contact
Regulation Number	884.6110   More FDA Info for this Regulation Number
Classification Product Code	MQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2005
Decision Date	01/30/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review