The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietex Monofilament Polyester Mesh.
| Device ID | K090858 |
| 510k Number | K090858 |
| Device Name: | PARIETEX MONOFILAMENT POLYESTER MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Angela Bunn |
| Correspondent | Angela Bunn SOFRADIM PRODUCTION 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 | 2009-03-30 |
| Decision Date | 2009-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521178915 | K090858 | 000 |
| 10884521178922 | K090858 | 000 |
| 20884521178882 | K090858 | 000 |
| 10884521178878 | K090858 | 000 |
| 10884521178939 | K090858 | 000 |
| 10884521178854 | K090858 | 000 |
| 20884521178868 | K090858 | 000 |
| 20884521178844 | K090858 | 000 |
| 10884521178892 | K090858 | 000 |
| 20884521178905 | K090858 | 000 |
| 10884521178830 | K090858 | 000 |