Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K113822
Device Classification Name
Device, Neurovascular Embolization
More FDA Info for this Device
510(K) Number
K113822
Device Name
Device, Neurovascular Embolization
Applicant
BIOSPHERE MEDICAL, INC.
1050 HINGHAM ST.
ROCKLAND, MA 02370 US
Other 510(k) Applications for this Company
Contact
LINDA J VARROSO
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
12/27/2011
Decision Date
03/08/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact