Device Classification Name |
heat-exchanger, cardiopulmonary bypass
|
510(k) Number |
K000977 |
Device Name |
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS |
Applicant |
OLSON MEDICAL SALES, INC. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
GARY A COURTNEY |
Correspondent |
OLSON MEDICAL SALES, INC. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
GARY A COURTNEY |
Regulation Number | 870.4240
|
Classification Product Code |
|
Date Received | 03/27/2000 |
Decision Date | 03/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|