Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K974897 |
Device Name |
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET |
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 | 12/31/1997 |
Decision Date | 03/31/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|