The following data is part of a premarket notification filed by I.m.p. Group Ltd. with the FDA for Infusion Needle Set.
| Device ID | K791529 |
| 510k Number | K791529 |
| Device Name: | INFUSION NEEDLE SET |
| Classification | Set, Administration, Intravascular |
| Applicant | I.M.P. GROUP LTD. 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 | 1979-08-10 |
| Decision Date | 1979-10-02 |