The following data is part of a premarket notification filed by Omnia Spa with the FDA for Ptfe Surgical Suture.
| Device ID | K180630 |
| 510k Number | K180630 |
| Device Name: | PTFE SURGICAL SUTURE |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Applicant | OMNIA SPA Via F. Delnevo, 190 Fidenza, IT 43036 |
| Contact | Roberto Cerioli |
| Correspondent | Marisa Testa THEMA SRL Via Saragat 5 Imola, IT 40026 |
| Product Code | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-09 |
| Decision Date | 2018-04-06 |