The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel Huber Infusion Set Rotating Wing.
| Device ID | K926119 |
| 510k Number | K926119 |
| Device Name: | EXEL HUBER INFUSION SET ROTATING WING |
| Classification | Set, Administration, Intravascular |
| Applicant | EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Contact | Hamid |
| Correspondent | Hamid EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-03 |
| Decision Date | 1993-08-11 |