The following data is part of a premarket notification filed by Sofradim Production with the FDA for Parietene Macroporous Mesh.
| Device ID | K142091 |
| 510k Number | K142091 |
| Device Name: | PARIETENE MACROPOROUS MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Jennifer Brennan |
| Correspondent | Jennifer Brennan 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 | 2014-08-01 |
| Decision Date | 2014-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521213753 | K142091 | 000 |
| 20884521213842 | K142091 | 000 |
| 20884521213835 | K142091 | 000 |
| 20884521213828 | K142091 | 000 |
| 20884521213811 | K142091 | 000 |
| 20884521213804 | K142091 | 000 |
| 10884521213791 | K142091 | 000 |
| 10884521213784 | K142091 | 000 |
| 10884521213777 | K142091 | 000 |
| 10884521213760 | K142091 | 000 |
| 10884521213746 | K142091 | 000 |
| 20884521213859 | K142091 | 000 |
| 20884521213866 | K142091 | 000 |
| 20884521214917 | K142091 | 000 |
| 20884521214900 | K142091 | 000 |
| 20884521214894 | K142091 | 000 |
| 20884521214887 | K142091 | 000 |
| 10884521214743 | K142091 | 000 |
| 10884521214736 | K142091 | 000 |
| 20884521213989 | K142091 | 000 |
| 20884521213972 | K142091 | 000 |
| 20884521213965 | K142091 | 000 |
| 10884521213876 | K142091 | 000 |
| 10884521213739 | K142091 | 000 |