Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K003828 |
Device Name |
VASO PRESS DVT FOOT GARMENT #VP 520 |
Applicant |
BRITT CORP., INC. |
16 CREST DR. |
COLTS NECK,
NJ
07722
|
|
Applicant Contact |
J J BRITTON |
Correspondent |
BRITT CORP., INC. |
16 CREST DR. |
COLTS NECK,
NJ
07722
|
|
Correspondent Contact |
J J BRITTON |
Regulation Number | 870.5800 |
Classification Product Code |
|
Date Received | 12/11/2000 |
Decision Date | 05/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|