Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K964021 |
Device Name |
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) |
Applicant |
BAXTER EDWARDS |
17221 RED HILL AVE. |
IRVINE,
CA
92714 -5686
|
|
Applicant Contact |
PAULA A TORRIANNI |
Correspondent |
BAXTER EDWARDS |
17221 RED HILL AVE. |
IRVINE,
CA
92714 -5686
|
|
Correspondent Contact |
PAULA A TORRIANNI |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 10/07/1996 |
Decision Date | 03/27/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|