510(k) DEN000006
DEN000006 is an FDA 510(k) premarket notification submitted by Urometrics, Inc. for the device "EROS-CLITORAL THERAPY DEVICE (CTD)". The FDA issued a decision of De Novo Granted on April 28, 2000. The device falls under product code NBV (Device, Engorgement, Clitoral), a Class II device regulated under 21 CFR 884.5970. Urometrics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 28, 2000
- Date Received
- April 27, 2000
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Engorgement, Clitoral
- Device Class
- Class II
- Regulation Number
- 884.5970
- Review Panel
- OB
- Submission Type