Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K984583 |
Device Name |
THE BIOPLATE SHUNT CONNECTOR |
Applicant |
BIOMEDICS |
536 RIMPAU BLVD. |
LOS ANGELES,
CA
90020
|
|
Applicant Contact |
ERIC V HOHENSTEIN |
Correspondent |
BIOMEDICS |
536 RIMPAU BLVD. |
LOS ANGELES,
CA
90020
|
|
Correspondent Contact |
ERIC V HOHENSTEIN |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 12/24/1998 |
Decision Date | 03/15/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|