Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K992465 |
Device Name |
SOPHY SU8 PRESSURE ADJUSTABLE VALVE |
Applicant |
SOPHYSA SA |
70 WALNUT ST. |
WELLESLEY,
MA
02481
|
|
Applicant Contact |
JACQUELINE MASSE |
Correspondent |
SOPHYSA SA |
70 WALNUT ST. |
WELLESLEY,
MA
02481
|
|
Correspondent Contact |
JACQUELINE MASSE |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 07/23/1999 |
Decision Date | 09/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|