Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K071318 |
Device Name |
MODIFICATION TO: STOCKERT S5 SYSTEM |
Applicant |
SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 05/10/2007 |
Decision Date | 07/06/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|