Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K093658 |
Device Name |
RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS |
Applicant |
RENU MEDICAL, INC. |
9800 EVERGREEN WAY |
EVERETT,
WA
98204
|
|
Applicant Contact |
L. BRUCE PIERSON |
Correspondent |
RENU MEDICAL, INC. |
9800 EVERGREEN WAY |
EVERETT,
WA
98204
|
|
Correspondent Contact |
L. BRUCE PIERSON |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 11/25/2009 |
Decision Date | 01/14/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|