Device Classification Name |
Oxygenator, Cardiopulmonary Bypass
|
510(k) Number |
K901250 |
Device Name |
PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR |
Applicant |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Applicant Contact |
ABATI, PHD |
Correspondent |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Correspondent Contact |
ABATI, PHD |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 03/16/1990 |
Decision Date | 06/11/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|