FDA Product Code
FDA Product Code NFM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.3320
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K060151 | ORBITAL TISSUE EXPANDER (OTE) | Innovia, LLC | 2006-08-08 | Traditional | PDF ↗ |
| K010852 | OSMED TISSUE EXPANDER | Iop, Inc. | 2001-08-13 | Traditional | PDF ↗ |
Product code NFM · Class II · Ophthalmic. Data: openFDA.