Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K910938 |
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 |
JEANETTE G CLOUTIER |
Correspondent |
Codman & Shurtleff, Inc. |
41 PACELLA PARK DR. |
RANDOLPH INDUSTRIAL PARK |
RANDOLPH,
MA
02368 -1794
|
|
Correspondent Contact |
JEANETTE G CLOUTIER |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 03/06/1991 |
Decision Date | 08/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|