The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel Huber Needle.
| Device ID | K895769 |
| 510k Number | K895769 |
| Device Name: | EXEL HUBER NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Contact | Eshagh Hamid |
| Correspondent | Eshagh Hamid EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1990-02-16 |