The following data is part of a premarket notification filed by Coeur Laboratories, Inc. with the FDA for Coeur Control Syringe.
| Device ID | K874579 |
| 510k Number | K874579 |
| Device Name: | COEUR CONTROL SYRINGE |
| Classification | Syringe, Piston |
| Applicant | COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Contact | S Densmore |
| Correspondent | S Densmore COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-06 |
| Decision Date | 1988-01-19 |