Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K854049 |
Device Name |
HEYER-SCHULTE SYRINGO PERITONEAL SHUNT |
Applicant |
AMERICAN V. MUELLER |
6600 W. TOUHY |
CHICAGO,
IL
60648
|
|
Applicant Contact |
MATTHEW NOWLAND |
Correspondent |
AMERICAN V. MUELLER |
6600 W. TOUHY |
CHICAGO,
IL
60648
|
|
Correspondent Contact |
MATTHEW NOWLAND |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 10/03/1985 |
Decision Date | 11/27/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|