510(k) DEN160005
- Device
- Hem-Avert Perianal Stabilizer
- Applicant
- Stetrix, Inc.
- 510(k) number
- DEN160005
- Product code
- PNU
- Decision
- Unknown (DENG)
- Decision date
- 2016-12-19
- Date received
- 2016-01-28
- Regulation
- 884.5210
- Classification name
- Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- MARK BUCHANAN
- Address
- 70 Clay St. Oakland TN US 38060 38060
FDA Registration Numbers#
- 3005550381
- 3010824458
- 3002907620
Source Documents#
510(k) summary PDF not indicated by FDA