The following data is part of a premarket notification filed by Imed Corp. with the FDA for Accuset Administration Set.
| Device ID | K823346 |
| 510k Number | K823346 |
| Device Name: | ACCUSET ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | IMED CORP. 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 | 1982-11-09 |
| Decision Date | 1982-11-30 |