FDA 510(k) Application Details - K964488

Device Classification Name	Balloon,Detachable,For Neurovascular Occlusion   More FDA Info for this Device
510(K) Number	K964488
Device Name	Balloon,Detachable,For Neurovascular Occlusion
Applicant	TARGET THERAPEUTICS 47201 LAKEVIEW DR. FREEMONT, CA 94538-6530 US Other 510(k) Applications for this Company
Contact	LYNN K BELL Other 510(k) Applications for this Contact
Regulation Number	882.5950   More FDA Info for this Regulation Number
Classification Product Code	MZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/1996
Decision Date	04/21/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review