Device Classification Name |
Goniometer, Ac-Powered
|
510(k) Number |
K852390 |
Device Name |
CMT 1000 |
Applicant |
PRESTIGELINE, INC. |
FIVE INEZ DR. |
P.O. BOX Q |
BRENTWOOD,
NY
11717
|
|
Applicant Contact |
DEL GIARNO |
Correspondent |
PRESTIGELINE, INC. |
FIVE INEZ DR. |
P.O. BOX Q |
BRENTWOOD,
NY
11717
|
|
Correspondent Contact |
DEL GIARNO |
Regulation Number | 888.1500
|
Classification Product Code |
|
Date Received | 06/05/1985 |
Decision Date | 07/19/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|