Submission Details
| 510(k) Number | K851711 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 1985 |
| Decision Date | June 11, 1985 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
K851711 is an FDA 510(k) clearance for the 600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE, a Forceps, Tooth Extractor, Surgical (Class I — General Controls, product code EMG), submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 11, 1985, 47 days after receiving the submission on April 25, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K851711 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 1985 |
| Decision Date | June 11, 1985 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EMG — Forceps, Tooth Extractor, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4565 |