The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Optimized Composite Mesh (pco-osx References).
| Device ID | K110816 |
| 510k Number | K110816 |
| Device Name: | PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION BIOSURGERY 15 CROSBY DRIVE Bedford, MA 01730 |
| Contact | James Mcmahon |
| Correspondent | James Mcmahon SOFRADIM PRODUCTION BIOSURGERY 15 CROSBY DRIVE Bedford, MA 01730 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-24 |
| Decision Date | 2011-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521179691 | K110816 | 000 |
| 10884521179806 | K110816 | 000 |
| 10884521179776 | K110816 | 000 |