Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K101915 |
Device Name |
VASOPRESS SUPREME MINI MODEL VP500DM |
Applicant |
COMPRESSION THERAPY CONCEPTS, INC. |
35 JAMES WAY |
EATONTOWN,
NJ
07724
|
|
Applicant Contact |
LEONARD NASS |
Correspondent |
COMPRESSION THERAPY CONCEPTS, INC. |
35 JAMES WAY |
EATONTOWN,
NJ
07724
|
|
Correspondent Contact |
LEONARD NASS |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 07/09/2010 |
Decision Date | 08/06/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|