Submission Details
| 510(k) Number | K821778 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 1982 |
| Decision Date | July 06, 1982 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
K821778 is an FDA 510(k) clearance for the BEACH DRESSING PLIER, a Forceps, Dressing, Dental (Class I — General Controls, product code EFL), submitted by Pacific Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1982, 19 days after receiving the submission on June 17, 1982. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K821778 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 1982 |
| Decision Date | July 06, 1982 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EFL — Forceps, Dressing, Dental |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4565 |