Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K012606 |
Device Name |
CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE |
Applicant |
CLEAR MEDICAL, INC. |
1776 136TH PL. NE |
BELLEVUE,
WA
98005
|
|
Applicant Contact |
RICHARD RADFORD |
Correspondent |
CLEAR MEDICAL, INC. |
1776 136TH PL. NE |
BELLEVUE,
WA
98005
|
|
Correspondent Contact |
RICHARD RADFORD |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 08/13/2001 |
Decision Date | 02/06/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|