Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K830894 |
Device Name |
H-H IN-LINE VALVED CATHETER 2 TYPES |
Applicant |
HOLTER-HAUSNER INTL. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
HOLTER-HAUSNER INTL. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 03/21/1983 |
Decision Date | 04/08/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|