Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K172537 |
Device Name |
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag |
Applicant |
Codman & Shurtleff, Inc. |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Applicant Contact |
Christopher Garete |
Correspondent |
Codman & Shurtleff, Inc. |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
Christopher Garete |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 08/22/2017 |
Decision Date | 10/16/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|