Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K944354 |
Device Name |
CONTOUR EMBOLI |
Applicant |
INTERVENTIONAL THERAPEUTICS CORP. |
48668 MILMONT DR. |
FREMONT,
CA
94538
|
|
Applicant Contact |
LYNN K BELL |
Correspondent |
INTERVENTIONAL THERAPEUTICS CORP. |
48668 MILMONT DR. |
FREMONT,
CA
94538
|
|
Correspondent Contact |
LYNN K BELL |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 08/30/1994 |
Decision Date | 12/13/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|