Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K033704 |
Device Name |
MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS |
Applicant |
VYGON US LLC |
2495 GENERAL ARMSTEAD AVE. |
NORRISTOWN,
PA
19403
|
|
Applicant Contact |
COURTNEY SMITH |
Correspondent |
VYGON US LLC |
2495 GENERAL ARMSTEAD AVE. |
NORRISTOWN,
PA
19403
|
|
Correspondent Contact |
COURTNEY SMITH |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 11/25/2003 |
Decision Date | 05/27/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|