FDA Product Code
FDA Product Code PNU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5210
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN160005 | Hem-Avert Perianal Stabilizer | Stetrix, Inc. | 2016-12-19 | Direct | — |
Product code PNU · Class II · Obstetrics/Gynecology. Data: openFDA.