Submission Details
| 510(k) Number | K851105 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 19, 1985 |
| Decision Date | May 15, 1985 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
K851105 is an FDA 510(k) clearance for the TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/, a Forceps, Tooth Extractor, Surgical (Class I — General Controls, product code EMG), submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on May 15, 1985, 57 days after receiving the submission on March 19, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K851105 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 19, 1985 |
| Decision Date | May 15, 1985 |
| Days to Decision | 57 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 |