K043063 is an FDA 510(k) clearance for the OXYBAND WOUND DRESSING, a Dressing, Wound, Occlusive (Class I — General Controls, product code NAD), submitted by Oxyband Technologies, Inc. (North Reading, US). The FDA issued a Cleared decision on March 24, 2005, 139 days after receiving the submission on November 5, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4020.
| 510(k) Number | K043063 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 05, 2004 |
| Decision Date | March 24, 2005 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NAD — Dressing, Wound, Occlusive |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4020 |