Device Classification Name |
saline, vascular access flush
|
510(k) Number |
K121050 |
Device Name |
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE |
Applicant |
BECTON DICKINSON & CO. |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Applicant Contact |
JOHN ROBERTS |
Correspondent |
BECTON DICKINSON & CO. |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Correspondent Contact |
JOHN ROBERTS |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 04/06/2012 |
Decision Date | 02/07/2013 |
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
|
Recalls |
CDRH Recalls
|
|
|