The following data is part of a De Novo classification by Dignitana Ab with the FDA for Dignitana Ab Dignicap System.
| DeNovo ID | DEN150010 |
| Device Name: | Dignitana AB DigniCap System |
| Classification | Scalp Cooling System |
| Applicant | DIGNITANA AB traktorgranden 3 Lund, SE Se-226 60 |
| Contact | Jan Richardsson |
| Product Code | PMC |
| CFR Regulation Number | 878.4360 [🔎] |
| 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 | 2015-03-06 |
| Decision Date | 2015-12-08 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |