The following data is part of a premarket notification filed by Sutures Ltd. with the FDA for Surgidek.
| Device ID | K943216 |
| 510k Number | K943216 |
| Device Name: | SURGIDEK |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | SUTURES LTD. VAUXHALL IND. ESTATE Ruabon, Wrexham, GB Ll14 6ha |
| Contact | Eleanor Jones |
| Correspondent | Eleanor Jones SUTURES LTD. VAUXHALL IND. ESTATE Ruabon, Wrexham, GB Ll14 6ha |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-05 |
| Decision Date | 1994-12-05 |