Device Classification Name |
electrode, depth
|
510(k) Number |
K944061 |
Device Name |
CUEVA CRANIAL NERVE ELECTRODE |
Applicant |
AD-TECH MEDICAL INSTRUMENT CORP. |
1901 WILLIAM ST. |
RACINE,
WI
53404 -1876
|
|
Applicant Contact |
DAVID A PUTZ |
Correspondent |
AD-TECH MEDICAL INSTRUMENT CORP. |
1901 WILLIAM ST. |
RACINE,
WI
53404 -1876
|
|
Correspondent Contact |
DAVID A PUTZ |
Regulation Number | 882.1330
|
Classification Product Code |
|
Date Received | 08/19/1994 |
Decision Date | 01/20/1995 |
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
|
|
|