Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K020033 |
Device Name |
MAXISTAT PVA FOAM EMBOLIZATION PARTICLES |
Applicant |
SURGICA CORP. |
5090 ROBERT J. MATHEWS PKWY. |
#4 |
EL DORADO HILLS,
CA
95762
|
|
Applicant Contact |
LOU MATSON |
Correspondent |
SURGICA CORP. |
5090 ROBERT J. MATHEWS PKWY. |
#4 |
EL DORADO HILLS,
CA
95762
|
|
Correspondent Contact |
LOU MATSON |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 01/04/2002 |
Decision Date | 05/31/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|