Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K160832 |
Device Name |
Penumbra Smart Coil |
Applicant |
PENUMBRA, INC. |
ONE PENUMBRA PLACE |
ALAMEDA,
CA
94502
|
|
Applicant Contact |
Charles DeNault |
Correspondent |
PENUMBRA, INC. |
ONE PENUMBRA PLACE |
ALAMEDA,
CA
94502
|
|
Correspondent Contact |
Charles DeNault |
Regulation Number | 882.5950
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/25/2016 |
Decision Date | 04/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|