Device Classification Name |
Dynamometer, Ac-Powered
|
510(k) Number |
K981730 |
FOIA Releasable 510(k) |
K981730
|
Device Name |
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 |
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 | 888.1240
|
Classification Product Code |
|
Date Received | 05/15/1998 |
Decision Date | 07/17/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|