The following data is part of a premarket notification filed by Medfusion Systems, Inc. with the FDA for Bent Winged Mini-vol Infusion Set.
| Device ID | K842143 |
| 510k Number | K842143 |
| Device Name: | BENT WINGED MINI-VOL INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDFUSION SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-07-20 |