Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K900483 |
Device Name |
VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU. |
Applicant |
BAXTER HEALTHCARE CORP. |
1425 LAKE COOK RD. |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
CHARLES B MCNEIL |
Correspondent |
BAXTER HEALTHCARE CORP. |
1425 LAKE COOK RD. |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
CHARLES B MCNEIL |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 02/01/1990 |
Decision Date | 08/29/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|