Device Classification Name |
Console, Heart-Lung Machine, Cardiopulmonary Bypass
|
510(k) Number |
K002118 |
Device Name |
STOCKERT COMPACT SYSTEM VERSION 2.0 |
Applicant |
STOECKERT INSTRUMENTE |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
CYNTHIA J. M. NOLTE |
Correspondent |
STOECKERT INSTRUMENTE |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
CYNTHIA J. M. NOLTE |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 07/13/2000 |
Decision Date | 08/09/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|