Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K022554 |
Device Name |
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM |
Applicant |
INTEGRA NEUROSCIENCES |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Applicant Contact |
DONNA WALLACE |
Correspondent |
INTEGRA NEUROSCIENCES |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Correspondent Contact |
DONNA WALLACE |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 08/02/2002 |
Decision Date | 08/23/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|