Device Classification Name |
device, muscle monitoring
|
510(k) Number |
K113677 |
Device Name |
GRINDCARE MEASURE |
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 | 890.1375
|
Classification Product Code |
|
Date Received | 12/14/2011 |
Decision Date | 04/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|