Device Classification Name |
device, biofeedback
|
510(k) Number |
K092675 |
Device Name |
GRINDCARE |
Applicant |
MEDOTECH A/S |
13417 QUIVAS ST |
WESTMINSTER,
CO
80234
|
|
Applicant Contact |
Calley Herzog |
Correspondent |
MEDOTECH A/S |
13417 QUIVAS ST |
WESTMINSTER,
CO
80234
|
|
Correspondent Contact |
Calley Herzog |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 09/01/2009 |
Decision Date | 03/03/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|