Submission Details
| 510(k) Number | K833800 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 1983 |
| Decision Date | January 04, 1984 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K833800 is an FDA 510(k) clearance for the BEECHER 20 GA. PROBE, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Beecher Medical Diagnostic Instrumentation (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984, 65 days after receiving the submission on October 31, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K833800 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 1983 |
| Decision Date | January 04, 1984 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4670 |