510(k) DEN140020
- Device
- ECLIPSE SYSTEM
- Applicant
- Pelvalon
- 510(k) number
- DEN140020
- Product code
- PJH
- Decision
- Unknown (DENG)
- Decision date
- 2015-02-12
- Date received
- 2014-06-24
- Regulation
- 876.5930
- Classification name
- Dynamic Rectal Control System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
- Expedited review
- Y
Applicant Contact#
- Contact
- CINDY DOMECUS
- Address
- 1171 Barroilhet Dr. Hillsborough CA US 94010 94010
FDA Registration Numbers#
- 1722684
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PJH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150558 | Eclipse System | Pelvalon, Inc. | 2015-11-12 |