Device Classification Name |
Media, Electroconductive
|
510(k) Number |
K983964 |
Device Name |
BATCH #6060 CONDUCTIVE GEL |
Applicant |
SKYLARK DEVICE CO., LTD. |
34 CHUNG SHAN NORTH RD., |
12TH FL., SEC. 3 |
TAIPEI,
TW
|
|
Applicant Contact |
GEORGE CHEN |
Correspondent |
SKYLARK DEVICE CO., LTD. |
34 CHUNG SHAN NORTH RD., |
12TH FL., SEC. 3 |
TAIPEI,
TW
|
|
Correspondent Contact |
GEORGE CHEN |
Regulation Number | 882.1275
|
Classification Product Code |
|
Date Received | 11/06/1998 |
Decision Date | 12/09/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|