Device Classification Name |
dynamometer, nonpowered
|
510(k) Number |
K894557 |
Device Name |
LIGHTSCOPE SET |
Applicant |
OPTIK |
2131ESPEY COURT |
SUITE 7 |
CRIFTIB,
MD
21114
|
|
Applicant Contact |
WILLIAMS M MACFIE |
Correspondent |
OPTIK |
2131ESPEY COURT |
SUITE 7 |
CRIFTIB,
MD
21114
|
|
Correspondent Contact |
WILLIAMS M MACFIE |
Regulation Number | 888.1250
|
Classification Product Code |
|
Date Received | 07/20/1989 |
Decision Date | 08/07/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|