The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Mr-iii.
| Device ID | K002261 |
| 510k Number | K002261 |
| Device Name: | MR-III |
| Classification | Suture, Nonabsorbable, Synthetic, Polyester |
| Applicant | SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Demetrios Tsakonas |
| Correspondent | Demetrios Tsakonas SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | GAS |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-25 |
| Decision Date | 2000-10-23 |
| Summary: | summary |