Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K161553 |
Device Name |
BD SafeAssist |
Applicant |
BECTON, DICKINSON AND COMPANY |
1 BECTON DR |
Franklin Lakes,
NJ
07417
|
|
Applicant Contact |
Meriam Youssef |
Correspondent |
BECTON, DICKINSON AND COMPANY |
1 BECTON DR |
Franklin Lakes,
NJ
07417
|
|
Correspondent Contact |
Meriam Youssef |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 06/06/2016 |
Decision Date | 07/06/2016 |
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
|
|
|