Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K973627 |
Device Name |
STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM |
Applicant |
COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY |
ARVADA,
CO
80004
|
|
Applicant Contact |
LYNNE LEONARD |
Correspondent |
COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY |
ARVADA,
CO
80004
|
|
Correspondent Contact |
LYNNE LEONARD |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 09/24/1997 |
Decision Date | 11/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|