Device Classification Name |
Defoamer, Cardiopulmonary Bypass
|
510(k) Number |
K853503 |
Device Name |
SHILEY 3L CARDIOTOMY RESERVOIR |
Applicant |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Applicant Contact |
DAVID B THOMAS |
Correspondent |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Correspondent Contact |
DAVID B THOMAS |
Regulation Number | 870.4230
|
Classification Product Code |
|
Date Received | 08/21/1985 |
Decision Date | 11/14/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|