Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K033850 |
Device Name |
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE |
Applicant |
MEDTRONIC NEUROSURGERY |
125 CREMONA DR., |
GOLETA,
CA
93117
|
|
Applicant Contact |
JEFFREY HENDERSON |
Correspondent |
MEDTRONIC NEUROSURGERY |
125 CREMONA DR., |
GOLETA,
CA
93117
|
|
Correspondent Contact |
JEFFREY HENDERSON |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 12/11/2003 |
Decision Date | 01/13/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|