Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K870976 |
Device Name |
ONGUARD 1000, CATALOG #043611-000 & 043611-001 |
Applicant |
COBE LABORATORIES, INC. |
1185 OAK ST. |
LAKEWOOD,
CO
80215
|
|
Applicant Contact |
VERA BUFFALOE |
Correspondent |
COBE LABORATORIES, INC. |
1185 OAK ST. |
LAKEWOOD,
CO
80215
|
|
Correspondent Contact |
VERA BUFFALOE |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 03/10/1987 |
Decision Date | 05/06/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|