K832911 is an FDA 510(k) clearance for the ABBOTT GLOBE HOLDER. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO).
Submitted by Miami Eye Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983, 31 days after receiving the submission on August 29, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K832911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1983 |
| Decision Date | September 29, 1983 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HJO — Biomicroscope, Slit-lamp, Ac-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.1850 |