Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K893578 |
Device Name |
PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS |
Applicant |
BAXTER HEALTHCARE CORP. |
27200 NORTH TOURNEY RD. |
P.O. BOX 5900 |
VALENCIA,
CA
91355 -8900
|
|
Applicant Contact |
LAWRENCE GETLIN |
Correspondent |
BAXTER HEALTHCARE CORP. |
27200 NORTH TOURNEY RD. |
P.O. BOX 5900 |
VALENCIA,
CA
91355 -8900
|
|
Correspondent Contact |
LAWRENCE GETLIN |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 05/09/1989 |
Decision Date | 08/01/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|