FDA 510(k) Application Details - K091958

Device Classification Name	Intrauterine Tamponade Balloon   More FDA Info for this Device
510(K) Number	K091958
Device Name	Intrauterine Tamponade Balloon
Applicant	GLENVEIGH SURGICAL, LLC 717 LAKEGLEN DRIVE SUWANEE, GA 30024 US Other 510(k) Applications for this Company
Contact	PENNY NORTHCUTT Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	OQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2009
Decision Date	04/30/2010
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