DEN160012 is an FDA 510(k) submission for the D2 Dressing. This device is classified as a Temporary, Internal Use Hemostatic (Class II - Special Controls, product code POD).
Submitted by Z-Medica, LLC (Wallingford, US). The FDA issued a Not Cleared (DENG) decision on June 30, 2017.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4454. Intended To Control Severely Bleeding Wounds.
| 510(k) Number | DEN160012 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 16, 2016 |
| Decision Date | June 30, 2017 |
| Days to Decision | 471 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | POD - Temporary, Internal Use Hemostatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4454 |
| Definition | Intended To Control Severely Bleeding Wounds |