SCLERAL SHELL
FDA 510(k) clearance K970320 · decided 1997-07-07
Clearance details
- K-number
- K970320
- Device name
- SCLERAL SHELL
- Applicant
- Xavier A. Guerra, Ocularist, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-28
- Decision date
- 1997-07-07
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- HQT
- Device class
- 2
- Regulation number
- 886.3800
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SCLERAL SHELL (K970327) | Southwest Artificial Eyes, Inc. | 1997-07-07 |
| ARTIFICIAL SCLERAL SHELL (K904961) | Midwest Eye Laboratories, Inc. | 1991-08-30 |
| SIMMONS SHELL (K855105) | Mira, Inc. | 1986-03-31 |
Recalls involving this device
No recalls on record reference this clearance.