K072560 is an FDA 510(k) clearance for the ENVELA (HYDROHESIVE OCCLUSIVE DRESSING), a Dressing, Wound, Occlusive (Class I — General Controls, product code NAD), submitted by Teikoku Pharma USA, Inc. (San Jose, US). The FDA issued a Cleared decision on June 17, 2008, 280 days after receiving the submission on September 11, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4020.
| 510(k) Number | K072560 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 2007 |
| Decision Date | June 17, 2008 |
| Days to Decision | 280 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 |