K060984 is an FDA 510(k) clearance for the XENFORM SOFT TISSUE REPAIR MATRIX. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on May 17, 2006, 37 days after receiving the submission on April 10, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K060984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2006 |
| Decision Date | May 17, 2006 |
| Days to Decision | 37 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |