K832912 is an FDA 510(k) clearance for the GELENDER VACUUM FIXATION RING SYS. This device is classified as a Ring, Ophthalmic (flieringa) (Class I - General Controls, product code HNH).
Submitted by Miami Eye Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984, 134 days after receiving the submission on August 29, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K832912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1983 |
| Decision Date | January 10, 1984 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNH — Ring, Ophthalmic (flieringa) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |