The following data is part of a premarket notification filed by Apogee, Inc. with the FDA for Low Pressure Injection Tubing, Coiled Line, Extension Tubing.
| Device ID | K942381 |
| 510k Number | K942381 |
| Device Name: | LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING |
| Classification | Injector And Syringe, Angiographic |
| Applicant | APOGEE, INC. 7517-101 PRECISION DR. Raleigh, NC 27613 |
| Contact | Diane N Peper |
| Correspondent | Diane N Peper APOGEE, INC. 7517-101 PRECISION DR. Raleigh, NC 27613 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-19 |
| Decision Date | 1995-03-17 |