K830867 is an FDA 510(k) clearance for the REFLEX ONE STAPLE EXTRACTOR..
Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983, 25 days after receiving the submission on March 18, 1983.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K830867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | March 18, 1983 |
| Decision Date | April 12, 1983 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |