Device Classification Name |
anesthesia conduction kit
|
510(k) Number |
K954953 |
Device Name |
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
ONE BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
GREGORY W MORGAN |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
ONE BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
GREGORY W MORGAN |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 10/30/1995 |
Decision Date | 05/20/1996 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|