The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Roentgenography Set & Pressure Monitoring Line.
| Device ID | K850861 |
| 510k Number | K850861 |
| Device Name: | ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Michael I Basta |
| Correspondent | Michael I Basta MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1986-02-18 |