Device Classification Name |
supplies, blood-bank
|
510(k) Number |
BK070036 |
Tradename |
Vortech Concentration System
|
Device Name |
Blood Bank Supplies |
Original Applicant |
Biomet Biologics, Inc. |
56 east bell drive |
po box 587 |
warsaw,
IN
46581
0587
|
|
Regulation Number | 864.9050
|
Classification Product Code |
|
Date Received | 06/28/2007 |
Decision Date | 11/21/2007 |
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
|
|
|