Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K041525 |
Device Name |
HEMOVAC BLOOD REINFUSION SYSTEM |
Applicant |
ZIMMER, INC. |
PO BOX 10 200 W. OHIO AVENUE |
DOVER,
OH
44622 -0010
|
|
Applicant Contact |
CINDY J DICKEY |
Correspondent |
ZIMMER, INC. |
PO BOX 10 200 W. OHIO AVENUE |
DOVER,
OH
44622 -0010
|
|
Correspondent Contact |
CINDY J DICKEY |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 06/08/2004 |
Decision Date | 10/14/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|