Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K010026 |
Device Name |
EMBOGOLD MICROSPHERE |
Applicant |
BIOSPHERE MEDICAL, INC. |
1050 HINGHAM ST. |
ROCKLAND,
MA
02370
|
|
Applicant Contact |
JOHN D BONASERA |
Correspondent |
BIOSPHERE MEDICAL, INC. |
1050 HINGHAM ST. |
ROCKLAND,
MA
02370
|
|
Correspondent Contact |
JOHN D BONASERA |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 01/03/2001 |
Decision Date | 06/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|