K870257 is an FDA 510(k) clearance for the POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T...
Submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on February 24, 1987, 32 days after receiving the submission on January 23, 1987.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K870257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1987 |
| Decision Date | February 24, 1987 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |