The following data is part of a premarket notification filed by Sofradim Production with the FDA for Pairetex Optimized Composite Mesh (pco-fx Refrences).
| Device ID | K110663 |
| 510k Number | K110663 |
| Device Name: | PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 15 CROSBY DRIVE Bedford, MA 01730 |
| Contact | James Mcmahon |
| Correspondent | James Mcmahon SOFRADIM PRODUCTION 15 CROSBY DRIVE Bedford, MA 01730 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-08 |
| Decision Date | 2011-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521179844 | K110663 | 000 |
| 10884521179813 | K110663 | 000 |
| 10884521179783 | K110663 | 000 |
| 10884521179752 | K110663 | 000 |
| 10884521179714 | K110663 | 000 |
| 10884521179684 | K110663 | 000 |
| 10884521179660 | K110663 | 000 |
| 10884521179868 | K110663 | 000 |
| 10884521179738 | K110663 | 000 |