The following data is part of a premarket notification filed by Sofradim Production with the FDA for Dextile Anatomical Mesh.
| Device ID | K192443 |
| 510k Number | K192443 |
| Device Name: | Dextile Anatomical Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Sofradim Production 116 Avenue Du Formans Trevoux, FR 01600 |
| Contact | Benjamin Rochette |
| Correspondent | Angela Van Arsdale 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 | 2019-09-06 |
| Decision Date | 2019-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521726543 | K192443 | 000 |
| 10884521726536 | K192443 | 000 |
| 10884521726529 | K192443 | 000 |
| 10884521726512 | K192443 | 000 |
| 10884521726505 | K192443 | 000 |
| 10884521726499 | K192443 | 000 |