Hem-Avert Perianal Stabilizer— 510(k) DEN160005
UnknownStetrix, Inc.
FDA 510(k) clearance DEN160005 for Hem-Avert Perianal Stabilizer, Unknown on 2016-12-19. Applicant: Stetrix, Inc.. Device class: 2.
Clearance details
- Applicant
- Stetrix, Inc.
- Product code
- Code PNU
- Device class
- Class 2
- Regulation
- 21 CFR 884.5210
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Oakland, TN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.