Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K944222 |
Device Name |
CODMAN-MEDOS VALVE SHUNT SYSTEM |
Applicant |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
41 PACELLA PARK DR. |
RANDOLPH IND. PARK |
RANDOLPH,
MA
02368
|
|
Applicant Contact |
PATRICIA BANKERT |
Correspondent |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
41 PACELLA PARK DR. |
RANDOLPH IND. PARK |
RANDOLPH,
MA
02368
|
|
Correspondent Contact |
PATRICIA BANKERT |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 08/30/1994 |
Decision Date | 07/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|