Device Classification Name |
Saline, Vascular Access Flush
|
510(k) Number |
K042061 |
Device Name |
0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE |
Applicant |
BECTON DICKINSON |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
PETER ZURLO |
Correspondent |
BECTON DICKINSON |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
PETER ZURLO |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 08/02/2004 |
Decision Date | 08/26/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|