The following data is part of a premarket notification filed by Sofradim Production with the FDA for Duatene Bilayer Mesh.
| Device ID | K172395 |
| 510k Number | K172395 |
| Device Name: | Duatene Bilayer Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Sofradim Production 116 Avenue Du Formans Trevoux, FR 01600 |
| Contact | Benjamin Rochette |
| Correspondent | Jose Marquez Covidien 60 Middletown Avenue North Haven, CT 06473 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-08 |
| Decision Date | 2018-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521726632 | K172395 | 000 |
| 20884521726649 | K172395 | 000 |
| 20884521726625 | K172395 | 000 |
| 20884521726618 | K172395 | 000 |
| 20884521726601 | K172395 | 000 |
| 20884521726595 | K172395 | 000 |
| 10884521726581 | K172395 | 000 |
| 10884521726574 | K172395 | 000 |
| 10884521726567 | K172395 | 000 |