Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K892215 |
Device Name |
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT |
Applicant |
Codman & Shurtleff, Inc. |
41 PACELLA PARK DR. |
RANDOLPH INDUSTRIAL PARK |
RANDOLPH,
MA
02368 -1794
|
|
Applicant Contact |
THOMAS J COURAGE |
Correspondent |
Codman & Shurtleff, Inc. |
41 PACELLA PARK DR. |
RANDOLPH INDUSTRIAL PARK |
RANDOLPH,
MA
02368 -1794
|
|
Correspondent Contact |
THOMAS J COURAGE |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 04/03/1989 |
Decision Date | 08/21/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|