Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K002938 |
Device Name |
B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
PETER ZURLO |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
PETER ZURLO |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 09/21/2000 |
Decision Date | 11/29/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|