The following data is part of a premarket notification filed by Y with the FDA for Infusion Set-52-05-1 20 Drops-mi Vol.
| Device ID | K833033 |
| 510k Number | K833033 |
| Device Name: | INFUSION SET-52-05-1 20 DROPS-MI VOL |
| Classification | Set, Administration, Intravascular |
| Applicant | Y 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-07 |
| Decision Date | 1983-11-07 |