Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K071040 |
Device Name |
WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS |
Applicant |
WRIGHT LINEAR PUMP, INC. |
103-B INTERNATIONAL DR. |
OAKDALE,
PA
15071 -3907
|
|
Applicant Contact |
CAROL WRIGHT |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 04/12/2007 |
Decision Date | 05/22/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|