510(k) DEN130047
- Device
- PROLONG
- Applicant
- Ergon Medical , Ltd.
- 510(k) number
- DEN130047
- Product code
- PIA
- Decision
- Unknown (DENG)
- Decision date
- 2015-03-20
- Date received
- 2013-11-18
- Regulation
- 876.5025
- Classification name
- Vibrator For Climax Control Of Premature Ejaculation
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- BARRY PEARCE
- Address
- 25 Barker Close Fishbourne, Chichester West Sussex GB PO18 8BJ PO18 8BJ
FDA Registration Numbers#
- 3026270764
- 3033790325
- 3016159407
- 3012639861
- 3017552081
Source Documents#
510(k) summary PDF not indicated by FDA