Device Classification Name |
Dynamometer, Nonpowered
|
510(k) Number |
K970870 |
Device Name |
DIGIT-GRIP WITH LCD (DGR002) |
Applicant |
NK BIOTECHNICAL CORP. |
10850 OLD COUNTY RD. 15 |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
KAREN GOTFREDSON |
Correspondent |
NK BIOTECHNICAL CORP. |
10850 OLD COUNTY RD. 15 |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
KAREN GOTFREDSON |
Regulation Number | 888.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/10/1997 |
Decision Date | 05/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|