The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Fluid Administration Sets, 15 Micron.
| Device ID | K790314 |
| 510k Number | K790314 |
| Device Name: | FLUID ADMINISTRATION SETS, 15 MICRON |
| Classification | Filter, Infusion Line |
| Applicant | MEDEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-13 |
| Decision Date | 1979-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517069512 | K790314 | 000 |
| 50351688504980 | K790314 | 000 |
| 50351688504744 | K790314 | 000 |
| 50351688504768 | K790314 | 000 |
| 50351688504782 | K790314 | 000 |
| 50351688504805 | K790314 | 000 |
| 50351688504836 | K790314 | 000 |
| 50351688504850 | K790314 | 000 |
| 50351688504867 | K790314 | 000 |
| 50351688504874 | K790314 | 000 |
| 50351688504911 | K790314 | 000 |
| 50351688504928 | K790314 | 000 |
| 50351688506090 | K790314 | 000 |
| 50351688518932 | K790314 | 000 |
| 50351688508834 | K790314 | 000 |
| 50351688508841 | K790314 | 000 |
| 50351688504973 | K790314 | 000 |