The following data is part of a premarket notification filed by Anchor Products Co. with the FDA for Anchor Brand Surgical Needles.
| Device ID | K831648 |
| 510k Number | K831648 |
| Device Name: | ANCHOR BRAND SURGICAL NEEDLES |
| Classification | Needle, Suturing, Disposable |
| Applicant | ANCHOR PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAB |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-08-16 |