Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K153257 |
Device Name |
BD FlowSmart Set, MiniMed Pro-Set |
Applicant |
BECTON, DICKINSON AND COMPANY |
1 BECTON DRIVE |
FRANKLIN LAKES,
NJ
07666
|
|
Applicant Contact |
MATTHEW TRACHTENBERG |
Correspondent |
BECTON, DICKINSON AND COMPANY |
1 BECTON DRIVE |
FRANKLIN LAKES,
NJ
07666
|
|
Correspondent Contact |
MATTHEW TRACHTENBERG |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/10/2015 |
Decision Date | 12/11/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|