The following data is part of a premarket notification filed by Artimplant Ab with the FDA for Artelon Surgical Suture.
| Device ID | K032160 |
| 510k Number | K032160 |
| Device Name: | ARTELON SURGICAL SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | ARTIMPLANT AB 719 A STREET NE Washington, DC 20002 |
| Contact | Russ Pagano |
| Correspondent | Russ Pagano ARTIMPLANT AB 719 A STREET NE Washington, DC 20002 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-15 |
| Decision Date | 2003-11-17 |
| Summary: | summary |