Device Classification Name |
Media, Electroconductive
|
510(k) Number |
K944600 |
Device Name |
GRAHAM-FIELD SALINE ELECTROLYTE GEL |
Applicant |
CHESTER LABS, INC. |
3208 DIXIE HWY |
ERLANGER,
KY
41018
|
|
Applicant Contact |
VERA PRACHT |
Correspondent |
CHESTER LABS, INC. |
3208 DIXIE HWY |
ERLANGER,
KY
41018
|
|
Correspondent Contact |
VERA PRACHT |
Regulation Number | 882.1275
|
Classification Product Code |
|
Date Received | 09/19/1994 |
Decision Date | 11/20/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|