Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K894668 |
Device Name |
MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM |
Applicant |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Applicant Contact |
J MAZZARESE |
Correspondent |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Correspondent Contact |
J MAZZARESE |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 07/25/1989 |
Decision Date | 10/20/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|