Panels › Ophthalmic › Product code HQT · Class 2
Shell, Scleral
Regulation 886.3800
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HQT
| Company | 510(k)s | Recalls |
|---|---|---|
| Midwest Eye Laboratories, Inc. | 1 | 0 |
| Mira, Inc. | 1 | 0 |
| Southwest Artificial Eyes, Inc. | 1 | 0 |
| Xavier A. Guerra, Ocularist, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 7, 1997 | K970327 | SCLERAL SHELL Southwest Artificial Eyes, Inc. | HQT |
| Jul 7, 1997 | K970320 | SCLERAL SHELL Xavier A. Guerra, Ocularist, Inc. | HQT |
| Aug 30, 1991 | K904961 | ARTIFICIAL SCLERAL SHELL Midwest Eye Laboratories, Inc. | HQT |
| Mar 31, 1986 | K855105 | SIMMONS SHELL Mira, Inc. | HQT |
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