The following data is part of a De Novo classification by Urometrics, Inc. with the FDA for Eros-clitoral Therapy Device (ctd).
| DeNovo ID | DEN000006 |
| Device Name: | EROS-CLITORAL THERAPY DEVICE (CTD) |
| Classification | Device, Engorgement, Clitoral |
| Applicant | UROMETRICS, INC. 445 Etna St., Suite 56 St. Paul, MN 55106 |
| Contact | Philip A Messina |
| Product Code | NBV |
| CFR Regulation Number | 884.5970 [🔎] |
| Decision | Granted (DENG) |
| Review Advisory Board | Obstetrics/Gynecology |
| Classification Advisory | Obstetrics/Gynecology |
| Type | Post-NSE |
| Date Received | 2000-04-27 |
| Decision Date | 2000-04-28 |