K832366 is an FDA 510(k) clearance for the ZOLLER BURNED LIP CONFORMER. This device is classified as a Retractor, All Types (Class I - General Controls, product code EIG).
Submitted by Universal Prosthetics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1983, 70 days after receiving the submission on July 18, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K832366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1983 |
| Decision Date | September 26, 1983 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIG — Retractor, All Types |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |