The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Progrip Mesh (new Name: Progrip Self-gripping Polyester Mesh), Parietex Plug And Patch (new Name : Parietex Plug And Patch System), Progrip Laparoscopic Self-fixating Mesh.
| Device ID | K142900 |
| 510k Number | K142900 |
| Device Name: | Parietex Progrip Mesh (new Name: Progrip Self-Gripping Polyester Mesh), Parietex Plug And Patch (new Name : Parietex Plug And Patch System), Progrip Laparoscopic Self-Fixating Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 116 AVENUE DU FORMANS Trevoux, FR 01600 |
| Contact | Eric Jague |
| Correspondent | Mary Mellows Surgical Devices , A Global Business Unit Of Covidien 60 Middleton Avenue North Haven, CT 06473 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-06 |
| Decision Date | 2014-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521513181 | K142900 | 000 |
| 10884521513174 | K142900 | 000 |
| 10884521513167 | K142900 | 000 |
| 10884521513143 | K142900 | 000 |
| 10884521513136 | K142900 | 000 |