Device Classification Name |
System, Isokinetic Testing And Evaluation
|
510(k) Number |
K844368 |
Device Name |
LINEAR LIFT DEVICE |
Applicant |
CYBEX |
2100 SMITHTOWN AVE. |
P.O. BOX 9003 |
RONKONKOMA,
NY
11779
|
|
Applicant Contact |
RAYMOND GIANNELLI |
Correspondent |
CYBEX |
2100 SMITHTOWN AVE. |
P.O. BOX 9003 |
RONKONKOMA,
NY
11779
|
|
Correspondent Contact |
RAYMOND GIANNELLI |
Regulation Number | 890.1925 |
Classification Product Code |
|
Date Received | 11/13/1984 |
Decision Date | 02/19/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|