The following data is part of a premarket notification filed by Jilin Coronado Medical Ltd. with the FDA for Colign.
| Device ID | K131124 |
| 510k Number | K131124 |
| Device Name: | COLIGN |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | JILIN CORONADO MEDICAL LTD. 9 South-Western Ring Road Fengman Economic Development Zone Jilin, CN 132016 |
| Contact | Eric Chien |
| Correspondent | Eric Chien JILIN CORONADO MEDICAL LTD. 9 South-Western Ring Road Fengman Economic Development Zone Jilin, CN 132016 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-22 |
| Decision Date | 2013-08-28 |
| Summary: | summary |