Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K862303 |
Device Name |
BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. |
Applicant |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
P.O. BOX 2090 |
GOLETA,
CA
93118
|
|
Applicant Contact |
STEPHEN W LAGUETTE |
Correspondent |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
P.O. BOX 2090 |
GOLETA,
CA
93118
|
|
Correspondent Contact |
STEPHEN W LAGUETTE |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 06/17/1986 |
Decision Date | 08/12/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|