The following data is part of a premarket notification filed by Coeur Laboratories, Inc. with the FDA for Front Load Injector Turret Model 859-0001/200 Ml Front Load Syringe Model 853-0211.
| Device ID | K960965 |
| 510k Number | K960965 |
| Device Name: | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 |
| Classification | Injector And Syringe, Angiographic |
| Applicant | COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Contact | James M Clinton |
| Correspondent | James M Clinton 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 | 1996-03-11 |
| Decision Date | 1996-09-12 |