510(k) DEN000006
- Device
- EROS-CLITORAL THERAPY DEVICE (CTD)
- Applicant
- Urometrics, Inc.
- 510(k) number
- DEN000006
- Product code
- NBV
- Decision
- Unknown (DENG)
- Decision date
- 2000-04-28
- Date received
- 2000-04-27
- Regulation
- 884.5970
- Classification name
- Device, Engorgement, Clitoral
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- PHILIP A MESSINA
- Address
- 445 Etna St., Suite 56 St. Paul MN US 55106 55106
Source Documents#
510(k) summary PDF not indicated by FDA