The following data is part of a premarket notification filed by Omnia Spa with the FDA for Ptfe Surgical Suture.
| Device ID | K132464 |
| 510k Number | K132464 |
| Device Name: | PTFE SURGICAL SUTURE |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Applicant | OMNIA SPA VIA SARAGAT 5 Imola, Bo, IT 40026 |
| Contact | Marco Manduchi |
| Correspondent | Marco Manduchi OMNIA SPA VIA SARAGAT 5 Imola, Bo, IT 40026 |
| Product Code | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-07 |
| Decision Date | 2014-02-12 |