Device Classification Name |
Electrode, Cutaneous
|
510(k) Number |
K050469 |
Device Name |
EZ-STIK ELECTRODES |
Applicant |
NAIMCO, INC. |
4120 SOUTH CREEK ROAD |
CHATTANOOGA,
TN
37406
|
|
Applicant Contact |
ROBERT L MCCLURE |
Correspondent |
NAIMCO, INC. |
4120 SOUTH CREEK ROAD |
CHATTANOOGA,
TN
37406
|
|
Correspondent Contact |
ROBERT L MCCLURE |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 02/23/2005 |
Decision Date | 05/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|