Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K003284 |
Device Name |
PHLEBOPUMP, MODEL 1000 |
Applicant |
PREVENT PRODUCTS, INC. |
1167 OTTAWA AVE. |
W ST PAUL,
MN
55118
|
|
Applicant Contact |
CAROL A GARCIA |
Correspondent |
PREVENT PRODUCTS, INC. |
1167 OTTAWA AVE. |
W ST PAUL,
MN
55118
|
|
Correspondent Contact |
CAROL A GARCIA |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 10/19/2000 |
Decision Date | 01/17/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|