Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K974145 |
Device Name |
V3 VALVE |
Applicant |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. |
BETHLEHEM,
PA
18018
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. |
BETHLEHEM,
PA
18018
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 11/03/1997 |
Decision Date | 01/06/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|