Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K161170 |
Device Name |
BD Eclipse Hypodermic Needle |
Applicant |
Becton, Dickinson and Company |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Applicant Contact |
Priyanka Apte |
Correspondent |
Becton, Dickinson and Company |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Correspondent Contact |
Priyanka Apte |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 04/26/2016 |
Decision Date | 05/27/2016 |
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
|
|
|