Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K030289 |
FOIA Releasable 510(k) |
K030289
|
Device Name |
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N |
Applicant |
INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Applicant Contact |
DONNA WALLACE |
Correspondent |
INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Correspondent Contact |
DONNA WALLACE |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 01/28/2003 |
Decision Date | 02/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|