Device Classification Name |
Electrode, Cortical
|
510(k) Number |
K912760 |
Device Name |
AD-TECH EPIDURAL PEG ELECTRODE |
Applicant |
AD-TECH MEDICAL INSTRUMENT CORP. |
1901 WILLIAM ST. |
RACINE,
WI
53404 -1876
|
|
Applicant Contact |
DAVID PUTZ |
Correspondent |
AD-TECH MEDICAL INSTRUMENT CORP. |
1901 WILLIAM ST. |
RACINE,
WI
53404 -1876
|
|
Correspondent Contact |
DAVID PUTZ |
Regulation Number | 882.1310
|
Classification Product Code |
|
Date Received | 06/24/1991 |
Decision Date | 01/15/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|