510(k) K150558
- Device
- Eclipse System
- Applicant
- Pelvalon, Inc.
- 510(k) number
- K150558
- Product code
- PJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-12
- Date received
- 2015-03-04
- Regulation
- 876.5930
- Classification name
- Dynamic Rectal Control System
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MILES ROSEN
- Address
- 923 Thompson Pl. Sunnyvale CA US 94085 94085
FDA Registration Numbers#
- 1722684
Source Documents#
Other 510(k) Records For Product Code PJH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN140020 | ECLIPSE SYSTEM | Pelvalon | 2015-02-12 |
Legacy Summary#
summary
FDA Review#
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