Device Classification Name |
supplies, blood-bank
|
510(k) Number |
BK020051 |
Tradename |
Cascade Medical Fibrinet, Autologous Platelet System
|
Device Name |
Supplies, Blood-Bank |
Original Applicant |
Cascade Medical Enterprises, LLC |
20 greenup court |
wayne,
NJ
07470
|
|
Regulation Number | 864.9050
|
Classification Product Code |
|
Date Received | 11/04/2002 |
Decision Date | 12/20/2002 |
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
|
|
|