Submission Details
| 510(k) Number | K864266 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 1986 |
| Decision Date | November 28, 1986 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K864266 is an FDA 510(k) clearance for the OPHTHALMIC KNIFE & FORCEPS, a Forceps, Ophthalmic (Class I — General Controls, product code HNR), submitted by Western Medical Products, Inc. (Sherman Oaks, US). The FDA issued a Cleared decision on November 28, 1986, 30 days after receiving the submission on October 29, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K864266 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 1986 |
| Decision Date | November 28, 1986 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNR — Forceps, Ophthalmic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.4350 |