Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K974006 |
Device Name |
BECTON DICKINSON TWINPAK |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
ONE BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
GREG MORGON |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
ONE BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
GREG MORGON |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 10/21/1997 |
Decision Date | 01/22/1998 |
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
|
|
|