Device Classification Name |
monitor, blood-gas, on-line, cardiopulmonary bypass
|
510(k) Number |
K915265 |
Device Name |
CDI(TM) H/S CUVETTE, MODIFICATION |
Applicant |
3M COMPANY |
1311 VALENCIA AVE. |
TUSTIN,
CA
92680
|
|
Applicant Contact |
ANN-MARIE BUTLER |
Correspondent |
3M COMPANY |
1311 VALENCIA AVE. |
TUSTIN,
CA
92680
|
|
Correspondent Contact |
ANN-MARIE BUTLER |
Regulation Number | 870.4330
|
Classification Product Code |
|
Date Received | 11/19/1991 |
Decision Date | 01/15/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|