Device Classification Name |
Syringe, Piston
|
510(k) Number |
K113241 |
Device Name |
BD EMERALD SINGLE USE, HYPODERMIC SYRINGE |
Applicant |
BECTON DICKINSON |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
KARA MCKEE |
Correspondent |
BECTON DICKINSON |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
KARA MCKEE |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 11/02/2011 |
Decision Date | 11/28/2011 |
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
|
|
|