Device Classification Name |
device, monitoring, intracranial pressure
|
510(k) Number |
K983799 |
Device Name |
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL |
Applicant |
MEDTRONIC PS MEDICAL |
125 CREMONA DR. |
GOLETA,
CA
93117 -5500
|
|
Applicant Contact |
JEFFREY HENDERSON |
Correspondent |
MEDTRONIC PS MEDICAL |
125 CREMONA DR. |
GOLETA,
CA
93117 -5500
|
|
Correspondent Contact |
JEFFREY HENDERSON |
Regulation Number | 882.1620
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/28/1998 |
Decision Date | 01/26/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|