The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietene Ds Composite Mesh.
| Device ID | K163212 |
| 510k Number | K163212 |
| Device Name: | Parietene DS Composite Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Sofradim Production 116 Avenue Du Formans Trevoux, FR 01600 |
| Contact | Benjamin Rochette |
| Correspondent | Mary Mellows 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 | 2016-11-16 |
| Decision Date | 2017-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521553507 | K163212 | 000 |
| 20884521553559 | K163212 | 000 |
| 20884521553542 | K163212 | 000 |
| 20884521553535 | K163212 | 000 |
| 20884521553528 | K163212 | 000 |
| 10884521553491 | K163212 | 000 |
| 10884521553484 | K163212 | 000 |
| 10884521553477 | K163212 | 000 |
| 10884521553460 | K163212 | 000 |
| 10884521553453 | K163212 | 000 |
| 20884521784083 | K163212 | 000 |
| 20884521784090 | K163212 | 000 |
| 10884521795426 | K163212 | 000 |
| 10884521795419 | K163212 | 000 |
| 10884521795402 | K163212 | 000 |
| 10884521795396 | K163212 | 000 |
| 10884521795389 | K163212 | 000 |
| 10884521784130 | K163212 | 000 |
| 20884521784120 | K163212 | 000 |
| 10884521784116 | K163212 | 000 |
| 20884521784106 | K163212 | 000 |
| 10884521553446 | K163212 | 000 |