Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K123300 |
Device Name |
BD PEN NEEDLE |
Applicant |
BECTON DICKINSON & CO. |
1 BECTON DR. |
MC 372 |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
PASQUALE AMATO |
Correspondent |
BECTON DICKINSON & CO. |
1 BECTON DR. |
MC 372 |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
PASQUALE AMATO |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 10/23/2012 |
Decision Date | 01/18/2013 |
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
|
|
|