Device Classification Name |
syringe, piston
|
510(k) Number |
BK170033 |
Tradenames |
DUO Set,
DUO Set A,
DUPLOCATH Application Catheter,
DUPLOJECT
|
Device Name |
Syringe, piston |
Original Applicant |
Baxter Healthcare Corporation |
32650 north wilson rd |
round lake,
IL
60073
|
|
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 04/04/2017 |
Decision Date | 07/24/2017 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
General Hospital
|
Review Advisory Committee |
General Hospital
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
Yes
|
In Vitro Product |
No
|
|
|