Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K012979 |
Device Name |
COMPRESSIBLE LIMB SLEEVE |
Applicant |
MEDICAL DEVICE SERVICES, INC. |
144 WEST BRIGHAM RD. BLDG. E |
ST. GEORGE,
UT
84790
|
|
Applicant Contact |
RON EAMES |
Correspondent |
MEDICAL DEVICE SERVICES, INC. |
144 WEST BRIGHAM RD. BLDG. E |
ST. GEORGE,
UT
84790
|
|
Correspondent Contact |
RON EAMES |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 09/05/2001 |
Decision Date | 05/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|