The following data is part of a premarket notification filed by S. Jackson, Inc. with the FDA for Shartpoint Eyed Needles.
| Device ID | K813589 |
| 510k Number | K813589 |
| Device Name: | SHARTPOINT EYED NEEDLES |
| Classification | Needle, Suturing, Reusable |
| Applicant | S. JACKSON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GDL |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-28 |
| Decision Date | 1982-01-18 |