HQT — Shell, Scleral Class II
FDA Device Classification
Classification Details
- Product Code
- HQT
- Device Class
- Class II
- Regulation Number
- 886.3800
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K970320 | xavier a. guerra, ocularist | SCLERAL SHELL | July 7, 1997 |
| K970327 | southwest artificial eyes | SCLERAL SHELL | July 7, 1997 |
| K904961 | midwest eye laboratories | ARTIFICIAL SCLERAL SHELL | August 30, 1991 |
| K855105 | mira | SIMMONS SHELL | March 31, 1986 |