Device Classification Name |
Catheter, Cholangiography
|
510(k) Number |
K926143 |
Device Name |
ANGIOLAPCATH CHOLANGIOGRAPHY KIT |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
MARCIA C LEATHAM |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
MARCIA C LEATHAM |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 12/07/1992 |
Decision Date | 07/07/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|