K862334 is an FDA 510(k) clearance for the CATALOG NO. I/A 100 AND KPE 200..
Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on July 8, 1986, 28 days after receiving the submission on June 10, 1986.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K862334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1986 |
| Decision Date | July 08, 1986 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | - |
| Device Class | - |