Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K881350 |
Device Name |
CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM |
Applicant |
STRYKER CORP. |
420 ALCOTT ST. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
HARMON WOODWORTH |
Correspondent |
STRYKER CORP. |
420 ALCOTT ST. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
HARMON WOODWORTH |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 03/30/1988 |
Decision Date | 09/30/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|