Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K854045 |
Device Name |
MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED |
Applicant |
AMERICAN BENTLEY |
17502 ARMSTRONG AVE. |
IRVINE,
CA
92714
|
|
Applicant Contact |
DONALD A RAIBLE |
Correspondent |
AMERICAN BENTLEY |
17502 ARMSTRONG AVE. |
IRVINE,
CA
92714
|
|
Correspondent Contact |
DONALD A RAIBLE |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 10/02/1985 |
Decision Date | 12/16/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|