K863989 is an FDA 510(k) clearance for the THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER). This device is classified as a Specula, Ophthalmic (Class I - General Controls, product code HNC).
Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on October 31, 1986, 17 days after receiving the submission on October 14, 1986.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K863989 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1986 |
| Decision Date | October 31, 1986 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNC — Specula, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |