Device Classification Name |
Syringe, Piston
|
510(k) Number |
K091377 |
Device Name |
BD FLU+ SYRINGE |
Applicant |
BECTON DICKINSON & CO. |
1 BECTON DRIVE MC237 |
FRANKLIN LAKES,
NJ
07417
|
|
Applicant Contact |
EILEEN HILLER |
Correspondent |
BECTON DICKINSON & CO. |
1 BECTON DRIVE MC237 |
FRANKLIN LAKES,
NJ
07417
|
|
Correspondent Contact |
EILEEN HILLER |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 05/11/2009 |
Decision Date | 07/02/2009 |
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
|
|
|