The following data is part of a premarket notification filed by Jilin Coronado Medical Ltd. with the FDA for Coseal.
| Device ID | K131411 |
| 510k Number | K131411 |
| Device Name: | COSEAL |
| Classification | Clamp, Vascular |
| Applicant | JILIN CORONADO MEDICAL LTD. 9 South-Western Circle Road Fenman Econormic Development Zone Jilin, CN 132016 |
| Contact | Eric Chien |
| Correspondent | Eric Chien JILIN CORONADO MEDICAL LTD. 9 South-Western Circle Road Fenman Econormic Development Zone Jilin, CN 132016 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2013-09-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COSEAL 75468469 2462093 Live/Registered |
BAXTER INTERNATIONAL INC. 1998-04-15 |
![]() COSEAL 74329962 not registered Dead/Abandoned |
American National Red Cross 1992-11-09 |
![]() COSEAL 73731695 1530428 Live/Registered |
TECHNICAL COATINGS CO. 1988-05-31 |