Device Classification Name |
container, empty, for collection & processing of blood & blood components
|
510(k) Number |
BK220785 |
Tradename |
Transfer Packs
|
Device Name |
Container, Empty, For the Collection '& Processing of Blood/Blood Components |
Original Applicant |
Fresenius Kabi AG |
else-kroner-strasse 1 |
Bad Homburg,
61352,
GERMANY
|
|
Regulation Number | 864.9100
|
Classification Product Code |
|
Date Received | 11/22/2022 |
Decision Date | 12/20/2022 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Special
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
No
|
|
|