Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K191684 |
Device Name |
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System |
Applicant |
Integra Lifesciences Corporation |
311 Enterprise Drive |
Plainsboro,
NJ
08536
|
|
Applicant Contact |
Omayra Ramirez |
Correspondent |
Integra Lifesciences Corporation |
311 Enterprise Drive |
Plainsboro,
NJ
08536
|
|
Correspondent Contact |
Omayra Ramirez |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 06/24/2019 |
Decision Date | 10/11/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|