Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K951254 |
Device Name |
SAFETYGLIDE NEEDLE |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
ONE BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
KAREN L ROSENCRANS |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
ONE BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
KAREN L ROSENCRANS |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 03/21/1995 |
Decision Date | 10/07/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|