The following data is part of a premarket notification filed by Coeur Laboratories, Inc. with the FDA for Coeur 130 Ml Angiographic Syringe.
| Device ID | K971712 |
| 510k Number | K971712 |
| Device Name: | COEUR 130 ML ANGIOGRAPHIC SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | COEUR LABORATORIES, INC. 5301 DEPATURE DR. Raleigh, NC 27604 |
| Contact | Christine L Panzl |
| Correspondent | Christine L Panzl 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 | 1997-05-09 |
| Decision Date | 1997-10-08 |
| Summary: | summary |