Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K940678 |
Device Name |
AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER |
Applicant |
BAXTER HEALTHCARE CORP. |
17511 ARMSTRONG AVE. |
P.O.BOX 19522 |
IRVINE,
CA
92713 -9522
|
|
Applicant Contact |
THOMAS J HUMPHREY |
Correspondent |
BAXTER HEALTHCARE CORP. |
17511 ARMSTRONG AVE. |
P.O.BOX 19522 |
IRVINE,
CA
92713 -9522
|
|
Correspondent Contact |
THOMAS J HUMPHREY |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 02/09/1994 |
Decision Date | 04/15/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|