Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K033350 |
Device Name |
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER |
Applicant |
BECTON DICKINSON & CO. |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Applicant Contact |
M. WENDY BALLESTEROS |
Correspondent |
BECTON DICKINSON & CO. |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Correspondent Contact |
M. WENDY BALLESTEROS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/20/2003 |
Decision Date | 11/18/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|