Device Classification Name |
syringe, piston
|
510(k) Number |
K121283 |
Device Name |
BD EMERALD SAF-T SINGLE USE, HYPODERMIC |
Applicant |
Becton, Dickinson and Company |
1 BECTON DRIVE MC237 |
FRANKLIN LAKES,
NJ
07417
|
|
Applicant Contact |
KIMBERLY LANE |
Correspondent |
Becton, Dickinson and Company |
1 BECTON DRIVE MC237 |
FRANKLIN LAKES,
NJ
07417
|
|
Correspondent Contact |
KIMBERLY LANE |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 04/30/2012 |
Decision Date | 05/30/2012 |
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
|
|
|