510(k) DEN130047
DEN130047 is an FDA 510(k) premarket notification submitted by Ergon Medical , Ltd. for the device "PROLONG". The FDA issued a decision of De Novo Granted on March 20, 2015. The device falls under product code PIA (Vibrator For Climax Control Of Premature Ejaculation), a Class II device regulated under 21 CFR 876.5025.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 20, 2015
- Date Received
- November 18, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vibrator For Climax Control Of Premature Ejaculation
- Device Class
- Class II
- Regulation Number
- 876.5025
- Review Panel
- GU
- Submission Type
Vibrator for climax control training for the treatment of premature ejaculation.