Device Classification Name |
pump, infusion
|
510(k) Number |
K844719 |
Device Name |
360 INFUSER |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
RUSSELL J ARNSBERGE |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
RUSSELL J ARNSBERGE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/04/1984 |
Decision Date | 01/28/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|