Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K902394 |
Device Name |
RESUBMITTED MULTIORGAN PERFUSION CANNULA |
Applicant |
FRESENIUS USA, INC. |
120 ALBANY ST. |
P.O. BOX 2623 |
NEW BRUNSWICK,
NJ
08903
|
|
Applicant Contact |
RON GUIDO |
Correspondent |
FRESENIUS USA, INC. |
120 ALBANY ST. |
P.O. BOX 2623 |
NEW BRUNSWICK,
NJ
08903
|
|
Correspondent Contact |
RON GUIDO |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 05/30/1990 |
Decision Date | 09/27/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|