FDA 510(k) Application Details - K991549

Device Classification Name	Device, Neurovascular Embolization   More FDA Info for this Device
510(K) Number	K991549
Device Name	Device, Neurovascular Embolization
Applicant	BIOSPHERE MEDICAL 1050 HINGHAM ST. ROCKLAND, MA 02370 US Other 510(k) Applications for this Company
Contact	SHEILA HEMEON-HEYER Other 510(k) Applications for this Contact
Regulation Number	882.5950   More FDA Info for this Regulation Number
Classification Product Code	HCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/1999
Decision Date	04/26/2000
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