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 |