The following data is part of a premarket notification filed by Sutures Ltd. with the FDA for Surgisorb.
| Device ID | K990432 |
| 510k Number | K990432 |
| Device Name: | SURGISORB |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| 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 | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-11 |
| Decision Date | 1999-05-27 |