| Device Classification Name |
Sleeve, Limb, Compressible
|
| 510(k) Number |
K061814 |
| Device Name |
VASOPRESS DVT SYSTEM, MODEL VP500D |
| Applicant |
| Compression Therapy Concepts, Inc. |
| 1750 Brielle Ave. Suite B6 |
|
Wanamassa,
NJ
07712
|
|
| Applicant Contact |
LEONARD NASS |
| Correspondent |
| Compression Therapy Concepts, Inc. |
| 1750 Brielle Ave. Suite B6 |
|
Wanamassa,
NJ
07712
|
|
| Correspondent Contact |
LEONARD NASS |
| Regulation Number | 870.5800 |
| Classification Product Code |
|
| Date Received | 06/27/2006 |
| Decision Date | 11/30/2006 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|