Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K820312 |
Device Name |
H-H RICKHAM TYPE RESERVOIR |
Applicant |
HOLTER-HAUSNER INTL. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HOLTER-HAUSNER INTL. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 02/05/1982 |
Decision Date | 03/01/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|