Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K902257 |
Device Name |
CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II) |
Applicant |
Codman & Shurtleff, Inc. |
41 PACELLA PARK DR. |
RANDOLPH INDUSTRIAL PARK |
RANDOLPH,
MA
02368 -1794
|
|
Applicant Contact |
DONALD A LINCOLN |
Correspondent |
Codman & Shurtleff, Inc. |
41 PACELLA PARK DR. |
RANDOLPH INDUSTRIAL PARK |
RANDOLPH,
MA
02368 -1794
|
|
Correspondent Contact |
DONALD A LINCOLN |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 05/21/1990 |
Decision Date | 07/19/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|