| DeNovo ID | DEN160012 |
| Device Name: | D2 Dressing |
| Classification | Temporary, Internal Use Hemostatic |
| Applicant | Z-MEDICA, LLC 4 Fairfield Boulevard Wallingford, CT 06492 |
| Contact | Sheila K. Wallin |
| Product Code | POD |
| CFR Regulation Number | 878.4454 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2016-03-16 |
| Decision Date | 2017-06-30 |
| Reclassification Order: | Reclassification Order |