Device Classification Name |
Syringe, Piston
|
510(k) Number |
K110771 |
Device Name |
BD SINGLE USE, HYPODERMIC SYRINGE |
Applicant |
Becton, Dickinson and Company |
1 BECTON DRIVE MC237 |
FRANKLIN LAKES,
NJ
07417
|
|
Applicant Contact |
JOHN ROBERTS |
Correspondent |
Becton, Dickinson and Company |
1 BECTON DRIVE MC237 |
FRANKLIN LAKES,
NJ
07417
|
|
Correspondent Contact |
JOHN ROBERTS |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 03/21/2011 |
Decision Date | 05/13/2011 |
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
|
Recalls |
CDRH Recalls
|
|
|