Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K991986 |
Device Name |
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION |
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 | 06/14/1999 |
Decision Date | 09/09/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|