The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel Spinal Needles.
| Device ID | K895771 |
| 510k Number | K895771 |
| Device Name: | EXEL SPINAL NEEDLES |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10020221269762 | K895771 | 000 |
| 10020221269625 | K895771 | 000 |
| 10020221269632 | K895771 | 000 |
| 10020221269663 | K895771 | 000 |
| 10020221269687 | K895771 | 000 |
| 10020221269694 | K895771 | 000 |
| 10020221269717 | K895771 | 000 |
| 10020221269724 | K895771 | 000 |
| 10020221269731 | K895771 | 000 |
| 10020221269601 | K895771 | 000 |
| 20020221269615 | K895771 | 000 |
| 20020221269646 | K895771 | 000 |
| 20020221269653 | K895771 | 000 |
| 20020221269677 | K895771 | 000 |
| 20020221269707 | K895771 | 000 |
| 10020221269748 | K895771 | 000 |
| 10020221269755 | K895771 | 000 |
| 10020221295563 | K895771 | 000 |