Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K973378 |
Device Name |
C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 |
Applicant |
FRESENIUS USA, INC. |
2637 SHADELANDS DR. |
WALNUT CREEK,
CA
94598
|
|
Applicant Contact |
VIRGINIA SINGER |
Correspondent |
FRESENIUS USA, INC. |
2637 SHADELANDS DR. |
WALNUT CREEK,
CA
94598
|
|
Correspondent Contact |
VIRGINIA SINGER |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 09/08/1997 |
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
|
|
|