The following data is part of a premarket notification filed by Sofradim Production with the FDA for Symbotex(tm) Composite Mesh.
| Device ID | K131969 |
| 510k Number | K131969 |
| Device Name: | SYMBOTEX(TM) COMPOSITE MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SOFRADIM PRODUCTION 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Clare Santulli |
| Correspondent | Clare Santulli 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 | 2013-06-28 |
| Decision Date | 2013-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521190603 | K131969 | 000 |
| 10884521593435 | K131969 | 000 |
| 10884521190634 | K131969 | 000 |
| 10884521190580 | K131969 | 000 |
| 10884521190511 | K131969 | 000 |
| 10884521190481 | K131969 | 000 |
| 10884521190450 | K131969 | 000 |
| 10884521190375 | K131969 | 000 |
| 10884521190368 | K131969 | 000 |
| 10884521190351 | K131969 | 000 |
| 10884521593442 | K131969 | 000 |
| 10884521190399 | K131969 | 000 |
| 10884521190627 | K131969 | 000 |
| 10884521190566 | K131969 | 000 |
| 10884521190542 | K131969 | 000 |
| 10884521190535 | K131969 | 000 |
| 10884521190504 | K131969 | 000 |
| 10884521190474 | K131969 | 000 |
| 10884521190467 | K131969 | 000 |
| 10884521190436 | K131969 | 000 |
| 10884521190412 | K131969 | 000 |
| 10884521190344 | K131969 | 000 |