Device Classification Name |
control, pump speed, cardiopulmonary bypass
|
510(k) Number |
K032213 |
Device Name |
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP |
Applicant |
STOCKERT INSTRUMENTE GMBH |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
CYNTHIA J.M. NOLTE |
Correspondent |
STOCKERT INSTRUMENTE GMBH |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
CYNTHIA J.M. NOLTE |
Regulation Number | 870.4380
|
Classification Product Code |
|
Date Received | 07/21/2003 |
Decision Date | 08/29/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|