Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K040943 |
Device Name |
MEDTRONIC PS MEDICAL STRATA VALVE |
Applicant |
MEDTRONIC NEUROSURGERY |
125 CREMONA DR., |
GOLETA,
CA
93117
|
|
Applicant Contact |
JEFF HENDERSON |
Correspondent |
MEDTRONIC NEUROSURGERY |
125 CREMONA DR., |
GOLETA,
CA
93117
|
|
Correspondent Contact |
JEFF HENDERSON |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 04/12/2004 |
Decision Date | 06/15/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|