Device Classification Name |
Device, Monitoring, Intracranial Pressure
|
510(k) Number |
K002392 |
Device Name |
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V |
Applicant |
INTEGRA NEUROCARE LLC. |
5955 PACIFIC CENTER BLVD. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
NANCY MATHEWSON |
Correspondent |
INTEGRA NEUROCARE LLC. |
5955 PACIFIC CENTER BLVD. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
NANCY MATHEWSON |
Regulation Number | 882.1620
|
Classification Product Code |
|
Date Received | 08/07/2000 |
Decision Date | 11/02/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|