Device Classification Name |
container, empty, for collection & processing of blood & blood components
|
510(k) Number |
BK950007 |
Tradename |
ESP White Cell Filter (No. 790F)
|
Device Name |
Container, Empty, For the Collection '& Processing of Blood/Blood Components |
Original Applicant |
Haemonetics Corporation |
400 wood road |
braintree,
MA
02184
9114
|
|
Regulation Number | 864.9100
|
Classification Product Code |
|
Date Received | 12/12/1994 |
Decision Date | 06/28/1995 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
No
|
|
|