Device Classification Name |
Pump, Blood, Cardiopulmonary Bypass, Roller Type
|
510(k) Number |
K953904 |
Device Name |
SARNS 9000 UNIVERSAL ROLLER PUMP |
Applicant |
3M HEALTH CARE, LTD. |
6200 JACKSON RD. |
P.O. BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Applicant Contact |
CHERYL ROSENBERG |
Correspondent |
3M HEALTH CARE, LTD. |
6200 JACKSON RD. |
P.O. BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Correspondent Contact |
CHERYL ROSENBERG |
Regulation Number | 870.4370
|
Classification Product Code |
|
Date Received | 08/18/1995 |
Decision Date | 04/19/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|