Submission Details
| 510(k) Number | K924774 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 1992 |
| Decision Date | April 14, 1993 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
K924774 is an FDA 510(k) clearance for the BURTON AUTOMATIC PROJECTOR - MODEL CP-40, a Clamp, Eyelid, Ophthalmic (Class I — General Controls, product code HOD), submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on April 14, 1993, 203 days after receiving the submission on September 23, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K924774 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 1992 |
| Decision Date | April 14, 1993 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HOD — Clamp, Eyelid, Ophthalmic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.4350 |