Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K131387 |
Device Name |
WRIGHT GRADIENT 52 - TORSO |
Applicant |
WRIGHT THERAPY PRODUCTS, INC |
103-B INTERNATIONAL DR. |
OAKDALE,
PA
15071
|
|
Applicant Contact |
CAROL WRIGHT |
Correspondent |
WRIGHT THERAPY PRODUCTS, INC |
103-B INTERNATIONAL DR. |
OAKDALE,
PA
15071
|
|
Correspondent Contact |
CAROL WRIGHT |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 05/14/2013 |
Decision Date | 11/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|