Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K822068 |
Device Name |
GAMBRO PUMP CONSOLE CSL |
Applicant |
GAMBRO, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
GAMBRO, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 07/14/1982 |
Decision Date | 08/24/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|