Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K892443 |
Device Name |
BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 |
Applicant |
GISH BIOMEDICAL, INC. |
2350 S. PULLMAN AVE. |
SANTA ANA,
CA
92705
|
|
Applicant Contact |
LORI GLASTETTER |
Correspondent |
GISH BIOMEDICAL, INC. |
2350 S. PULLMAN AVE. |
SANTA ANA,
CA
92705
|
|
Correspondent Contact |
LORI GLASTETTER |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 04/10/1989 |
Decision Date | 11/08/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|