K844142 is an FDA 510(k) clearance for the GORE-TEX TISSUE MATRIX..
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on June 28, 1985, 248 days after receiving the submission on October 23, 1984.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K844142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1984 |
| Decision Date | June 28, 1985 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |