Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K941653 |
Device Name |
SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION |
Applicant |
3M HEALTH CARE, SARNS |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Applicant Contact |
JOHN W TOIGO |
Correspondent |
3M HEALTH CARE, SARNS |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Correspondent Contact |
JOHN W TOIGO |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 04/05/1994 |
Decision Date | 08/24/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|