Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K022753 |
Device Name |
REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS |
Applicant |
MEDICAL DEVICE SERVICES |
144 WEST BRIGHAM RD. |
BLDG E |
ST. GEORGE,
UT
84790
|
|
Applicant Contact |
MARK ALDANA |
Correspondent |
MEDICAL DEVICE SERVICES |
144 WEST BRIGHAM RD. |
BLDG E |
ST. GEORGE,
UT
84790
|
|
Correspondent Contact |
MARK ALDANA |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 08/19/2002 |
Decision Date | 11/14/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|