FDA Product Code
FDA Product Code HQT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.3800
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K970320 | SCLERAL SHELL | Xavier A. Guerra, Ocularist, Inc. | 1997-07-07 | Traditional | PDF ↗ |
| K970327 | SCLERAL SHELL | Southwest Artificial Eyes, Inc. | 1997-07-07 | Traditional | PDF ↗ |
| K904961 | ARTIFICIAL SCLERAL SHELL | Midwest Eye Laboratories, Inc. | 1991-08-30 | Traditional | PDF ↗ |
| K855105 | SIMMONS SHELL | Mira, Inc. | 1986-03-31 | Traditional | PDF ↗ |
Product code HQT · Class II · Ophthalmic. Data: openFDA.