Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K212015 |
Device Name |
BD Nano 2nd Gen Pen Needle |
Applicant |
Becton Dickinson and Company |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Applicant Contact |
Charlton Foo |
Correspondent |
Becton Dickinson and Company |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Correspondent Contact |
Charlton Foo |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 06/28/2021 |
Decision Date | 11/19/2021 |
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
|
|
|