The following data is part of a premarket notification filed by Imed Corp. with the FDA for Accudot 380 Secondary I.v. Set.
| Device ID | K823027 |
| 510k Number | K823027 |
| Device Name: | ACCUDOT 380 SECONDARY I.V. SET |
| Classification | Set, Administration, Intravascular |
| Applicant | IMED CORP. 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 | 1982-10-14 |
| Decision Date | 1982-11-22 |