FDA Product Code
FDA Product Code LBM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3450
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K823441 | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE | Treace Medical, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K823442 | FISCH MODIFIED TOTAL OSSICULAR PROSTHES | Treace Medical, Inc. | 1982-12-03 | Traditional | PDF ↗ |
Product code LBM · Class II · Ear, Nose, Throat. Data: openFDA.