Device Classification Name |
adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
|
510(k) Number |
K131124 |
Device Name |
COLIGN |
Applicant |
JILIN CORONADO MEDICAL LTD. |
9 South-Western Ring Road |
Fengman Economic Development Zone |
Jilin,
CN
132016
|
|
Applicant Contact |
ERIC CHIEN |
Correspondent |
JILIN CORONADO MEDICAL LTD. |
9 South-Western Ring Road |
Fengman Economic Development Zone |
Jilin,
CN
132016
|
|
Correspondent Contact |
ERIC CHIEN |
Regulation Number | 870.4290
|
Classification Product Code |
|
Date Received | 04/22/2013 |
Decision Date | 08/28/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|