Device Classification Name |
goniometer, ac-powered
|
510(k) Number |
K913079 |
Device Name |
02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 |
Applicant |
LUCAS SENSING SYSTEMS, INC. |
21640 NORTH 14TH AVE. |
PHOENIX,
AZ
85027 -2839
|
|
Applicant Contact |
WAYNE SALUTE |
Correspondent |
LUCAS SENSING SYSTEMS, INC. |
21640 NORTH 14TH AVE. |
PHOENIX,
AZ
85027 -2839
|
|
Correspondent Contact |
WAYNE SALUTE |
Regulation Number | 888.1500
|
Classification Product Code |
|
Date Received | 07/11/1991 |
Decision Date | 09/25/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|