Device Classification Name |
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
|
510(k) Number |
K915363 |
Device Name |
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED) |
Applicant |
3M HEALTH CARE, LTD. |
6200 JACKSON RD. |
P.O. BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Applicant Contact |
NANCY P ATWOOD |
Correspondent |
3M HEALTH CARE, LTD. |
6200 JACKSON RD. |
P.O. BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Correspondent Contact |
NANCY P ATWOOD |
Regulation Number | 870.4360
|
Classification Product Code |
|
Date Received | 11/27/1991 |
Decision Date | 07/28/1993 |
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
|
|
|