Hem-Avert Perianal Stabilizer
FDA 510(k) clearance DEN160005 · decided 2016-12-19
Clearance details
- K-number
- DEN160005
- Device name
- Hem-Avert Perianal Stabilizer
- Applicant
- Stetrix, Inc.
- Decision
- Unknown
- Date received
- 2016-01-28
- Decision date
- 2016-12-19
- Days to decision
- 326 days
- Clearance type
- Direct
- Product code
- PNU
- Device class
- 2
- Regulation number
- 884.5210
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Oakland, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.