Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K974393 |
FOIA Releasable 510(k) |
K974393
|
Device Name |
VASO PRESS SYSTEM |
Applicant |
BRITT CORP., INC. |
PO BOX 547 |
FREEHOLD,
NJ
07728
|
|
Applicant Contact |
J. JAMES BRITTON |
Correspondent |
BRITT CORP., INC. |
PO BOX 547 |
FREEHOLD,
NJ
07728
|
|
Correspondent Contact |
J. JAMES BRITTON |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 11/21/1997 |
Decision Date | 03/19/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|