Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K960006 |
Device Name |
C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM |
Applicant |
FRESENIUS AG |
53 KENNEDY RD. |
FOSTER,
RI
02825
|
|
Applicant Contact |
ANNETTE M FAGNANT |
Correspondent |
FRESENIUS AG |
53 KENNEDY RD. |
FOSTER,
RI
02825
|
|
Correspondent Contact |
ANNETTE M FAGNANT |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 01/02/1996 |
Decision Date | 07/31/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|