The following data is part of a premarket notification filed by Sutures Ltd. with the FDA for Surgisteel.
| Device ID | K865038 |
| 510k Number | K865038 |
| Device Name: | SURGISTEEL |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | SUTURES LTD. VAUXHALL IND. ESTATE Ruabon, Wrexham, GB Ll14 6ha |
| Contact | Maragret Williams |
| Correspondent | Maragret Williams SUTURES LTD. VAUXHALL IND. ESTATE Ruabon, Wrexham, GB Ll14 6ha |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-24 |
| Decision Date | 1987-06-30 |