K883848 is an FDA 510(k) clearance for the KMI OXY-BAN. This device is classified as a Chamber, Oxygen, Topical, Extremity (Class II - Special Controls, product code KPJ).
Submitted by Knight Medical, Inc. (Houston, US). The FDA issued a Cleared decision on March 2, 1989, 171 days after receiving the submission on September 12, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5650.
| 510(k) Number | K883848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | September 12, 1988 |
| Decision Date | March 02, 1989 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KPJ — Chamber, Oxygen, Topical, Extremity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5650 |