Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K971799 |
Device Name |
PRECISION FLOW OSV II |
Applicant |
ELEKTA IMPLANTS, SA |
6011 CELLINI ST. |
CORAL GABLES,
FL
33146
|
|
Applicant Contact |
BARBARA RAMSEYER |
Correspondent |
ELEKTA IMPLANTS, SA |
6011 CELLINI ST. |
CORAL GABLES,
FL
33146
|
|
Correspondent Contact |
BARBARA RAMSEYER |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 05/15/1997 |
Decision Date | 02/06/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|