Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K053548 |
Device Name |
MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES |
Applicant |
PROTEIN POLYMER TECHNOLOGIES, INC. |
10655 SORRENTO VALLEY RD. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
R. STEPHEN REITZLER |
Correspondent |
PROTEIN POLYMER TECHNOLOGIES, INC. |
10655 SORRENTO VALLEY RD. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
R. STEPHEN REITZLER |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 12/20/2005 |
Decision Date | 01/30/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|