Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K980778 |
Device Name |
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM |
Applicant |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Applicant Contact |
DIANE MINEAR |
Correspondent |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
DIANE MINEAR |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 03/02/1998 |
Decision Date | 07/17/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|