The following data is part of a premarket notification filed by Coeur Laboratories, Inc. with the FDA for Coeurlock Sterile Dispos. Angiographic.
| Device ID | K823920 |
| 510k Number | K823920 |
| Device Name: | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC |
| Classification | Injector And Syringe, Angiographic |
| Applicant | COEUR LABORATORIES, INC. NC |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-28 |
| Decision Date | 1983-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40193489897853 | K823920 | 000 |