The following data is part of a premarket notification filed by Coeur Laboratories, Inc. with the FDA for Pca-10, 10cc Disp. Angiography Control Syringe.
| Device ID | K890292 |
| 510k Number | K890292 |
| Device Name: | PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Contact | Teresa R Mccleery |
| Correspondent | Teresa R Mccleery COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-19 |
| Decision Date | 1989-06-22 |